Open, ClassifiedPosted Jun 25, 2025·Initiated Apr 8, 2025
REMISOL Advance
UDI-DI code: 13700962601874
All Software Versions:
B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471
The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.
Reason: Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
Root cause: Software design
Recalling firm: Beckman Coulter Inc.Type: Calculator/Data Processing Module, For Clinical UseDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Australia, Austria, Bangladesh, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Czechia, Denmark, Ethiopia, France, French Polynesia, Germany, Greece, Guam, Hong Kong, India, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Kyrgyzstan, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Turkey, Uganda, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, and ZimbabweRecall #Z-2028-2025
Open, ClassifiedPosted Jun 24, 2025·Initiated May 23, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP.
Software Version: all
Product Description: The Omnipod 5 iOS App software is available to download
through the Apple app store.
The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.
Reason: Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
Root cause: Software design
Recalling firm: Insulet CorporationType: Continuous Glucose Monitor Informed Insulin Dose CalculatorDistribution: US market only- Although there are 122823 downloads of the application, our data shows there are only
~80k active users.Recall #Z-2016-2025
Open, ClassifiedPosted Jun 24, 2025·Initiated May 8, 2025
Product Name [REF]:
Supply Server,
CCE Enterprise SW Site License (2-5),
BD Pyxis Logistics [806],
BD Pyxis MedStation 4000 Main 10885403512629 [303],
BD Pyxis MedStation ES Tower 10885403512674 [352],
BD Pyxis Anesthesia Station ES 10885403477836 [327],
BD Pyxis MedStation ES (Main) 10885403512667 [323],
MD BD Pyxis SupplyStation V9 [317],
Security Module [139698-01],
BD Knowledge Portal for Medication Technologies [136607-01],
STOCKSTN V10.X WRD/WL SCANNERS [132-53-02],
PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01],
STOCKSTN V10.X WIRED SCANNER [132-52-02],
PRS STOCKSTN V10.X WIRED SCANNER [132-52-01],
BD Pyxis CII Safe ES Desktop PC [1156-00],
BD Pyxis SupplyStation Panel PC V11 [1132-00],
BD Pyxis SupplyRoller V11 [1127-00],
Dell 640 Server [1128-00],
BD Pyxis SupplyStation System V11 [1123-00],
BD Pyxis CII Safe ES 10885403512605 [1116-00],
BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00],
BD Pyxis SupplyRoller V10 [1101-00],
BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221],
BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194],
BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01],
BD Pyxis SupplyStation V10 [347],
BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01],
BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191],
BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198],
BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01],
BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01],
BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215],
BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216],
BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219],
Supply itParActive RF V11 (Supply Kanban) [138566-01]
Reason: During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Root cause: Software Design Change
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries of SA, CA, NZ , CH, FR, IT, BE, AU, BH, QA, AE, GB, EG, AR, JO, DE, BM, TH, LB, BR, IE, FI, MX, TW, ID, SG, BS, IN, MA, GF, ES, HK.
Open, ClassifiedPosted Jun 24, 2025·Initiated May 28, 2025
CDI OneView System BPM Probe:
Cat. No. CDI753 - CDI OneView BPM Probe,
Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Reason: Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Root cause: Employee error
Recalling firm: Terumo Cardiovascular Systems CorporationType: Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDistribution: US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.Recall #Z-2018-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-1999-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2000-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2001-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2002-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2003-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381811,
BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2004-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 382544
BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2005-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381923
BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2006-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 21, 2025
REF: 381434
BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Root cause: Component design/selection
Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.Recall #Z-2007-2025
Open, ClassifiedPosted Jun 23, 2025·Initiated May 28, 2025
Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm
Model/Catalog Number: 506-04-126
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Shoulder Prosthesis, Reverse ConfigurationDistribution: At time of quarantine:
RFK Medical Inc. Virginia (VA) CE102
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 4
Valor Medical Solutions South Texas (TX) CE118
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1
Joint Ventures Medical LLC Wisconsin (WI) CE121
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4
McCants Medical, LLC Florida (FL) CE128
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
Florida Direct - FSW Medical Florida (FL) FL001
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65
Great Lakes Medical Illinois (IL) GL108
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23
I & S Medical West Virginia (WV) & Kentucky (KY) GL113
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8
Osteo Solutions Ohio (OH), Kentucky (KY), GL114
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32
Procore Medical, LLC North Carolina (NC) MA102
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59
Medsource Rhode Island (RI), Massachusetts (MA) NE131
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12
506-04-126 5037A1017 ALTIVATE REVERSE TORX PER
Open, ClassifiedPosted Jun 23, 2025·Initiated May 28, 2025
Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm
Model/Catalog Number: 506-04-122
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Shoulder Prosthesis, Reverse ConfigurationDistribution: At time of quarantine:
RFK Medical Inc. Virginia (VA) CE102
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 4
Valor Medical Solutions South Texas (TX) CE118
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1
Joint Ventures Medical LLC Wisconsin (WI) CE121
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4
McCants Medical, LLC Florida (FL) CE128
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
Florida Direct - FSW Medical Florida (FL) FL001
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65
Great Lakes Medical Illinois (IL) GL108
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23
I & S Medical West Virginia (WV) & Kentucky (KY) GL113
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8
Osteo Solutions Ohio (OH), Kentucky (KY), GL114
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32
Procore Medical, LLC North Carolina (NC) MA102
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59
Medsource Rhode Island (RI), Massachusetts (MA) NE131
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12
506-04-126 5037A1017 ALTIVATE REVERSE TORX PER
Open, ClassifiedPosted Jun 23, 2025·Initiated May 28, 2025
Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm
Model/Catalog Number: 506-04-118
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Shoulder Prosthesis, Reverse ConfigurationDistribution: At time of quarantine:
RFK Medical Inc. Virginia (VA) CE102
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 4
Valor Medical Solutions South Texas (TX) CE118
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1
Joint Ventures Medical LLC Wisconsin (WI) CE121
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4
McCants Medical, LLC Florida (FL) CE128
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
Florida Direct - FSW Medical Florida (FL) FL001
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65
Great Lakes Medical Illinois (IL) GL108
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23
I & S Medical West Virginia (WV) & Kentucky (KY) GL113
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8
Osteo Solutions Ohio (OH), Kentucky (KY), GL114
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32
Procore Medical, LLC North Carolina (NC) MA102
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59
Medsource Rhode Island (RI), Massachusetts (MA) NE131
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12
506-04-126 5037A1017 ALTIVATE REVERSE TORX PER
Open, ClassifiedPosted Jun 23, 2025·Initiated May 28, 2025
Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm
Model/Catalog Number: 506-04-130
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Shoulder Prosthesis, Reverse ConfigurationDistribution: At time of quarantine:
RFK Medical Inc. Virginia (VA) CE102
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 4
Valor Medical Solutions South Texas (TX) CE118
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1
Joint Ventures Medical LLC Wisconsin (WI) CE121
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4
McCants Medical, LLC Florida (FL) CE128
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
Florida Direct - FSW Medical Florida (FL) FL001
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65
Great Lakes Medical Illinois (IL) GL108
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3
506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23
I & S Medical West Virginia (WV) & Kentucky (KY) GL113
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8
Osteo Solutions Ohio (OH), Kentucky (KY), GL114
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32
Procore Medical, LLC North Carolina (NC) MA102
506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14
506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2
506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59
Medsource Rhode Island (RI), Massachusetts (MA) NE131
506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3
506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12
506-04-126 5037A1017 ALTIVATE REVERSE TORX PER
Open, ClassifiedPosted Jun 23, 2025·Initiated Jun 11, 2025
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution
(32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Reason: Out of specification stability test result for the Caphosol B solution from process validation lots
Root cause: Device Design
Recalling firm: RECORDATI RARE DISEASES INC.Type: Saliva, ArtificialDistribution: Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.Recall #Z-2012-2025
Open, ClassifiedPosted Jun 20, 2025·Initiated May 15, 2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA
AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version
The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Reason: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Root cause: Process control
Recalling firm: SunMed Holdings, LLCType: Emergency Response Safety KitDistribution: US distribution nationwide. International distribution to Canada.Recall #Z-1904-2025
Open, ClassifiedPosted Jun 20, 2025·Initiated May 22, 2025
Extended Tip Applicator, 8CM, Box of 5.
Reason: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Root cause: Process change control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Syringe, PistonDistribution: Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.Recall #Z-1958-2025