Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 16, 2024
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure.
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Root cause: Use error
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Recall #Z-0030-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 16, 2024
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure.
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Root cause: Use error
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Recall #Z-0031-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 30, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Reason: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: System, Measurement, Blood-Pressure, Non-InvasiveDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.Recall #Z-0032-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 30, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Reason: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: System, Measurement, Blood-Pressure, Non-InvasiveDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.Recall #Z-0033-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 30, 2024
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Reason: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: System, Measurement, Blood-Pressure, Non-InvasiveDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.Recall #Z-0034-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Apr 19, 2023
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Reason: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
Root cause: Software design
Recalling firm: Philips North AmericaType: Detector And Alarm, ArrhythmiaDistribution: Worldwide - US Nationwide distribution.Recall #Z-0035-2025
Open, ClassifiedPosted Oct 7, 2024·Initiated Aug 30, 2024
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Reason: Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
Root cause: Under Investigation by firm
Recalling firm: Stryker NeurovascularType: Catheter, Percutaneous, NeurovasculatureDistribution: U.S. Nationwide distribution in the states of CA and VA.Recall #Z-0021-2025
Open, ClassifiedPosted Oct 7, 2024·Initiated Sep 4, 2024
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use.
Catalog Number: 5521-B-200
Reason: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
Root cause: Process control
Recalling firm: Howmedica Osteonics Corp.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.
Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. Letter states reason for recall, health risk and action to take:
1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product.
2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility.
3. Quarantine and discontinue use of the recalled devices identified in the affected product list (Table 1).
4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form:
" Medical Facility: Please sign the Business Reply Form and email to:
strykerortho8441@sedgwick.com/ Fax: (800) 871-7417
" Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email.
5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
6. Please return the devices to Stryker using the following address:
Stryker Orthopaedics/PFA Product Returns
Attn: Distribution Inventory Team
325 Corporate Drive
Dock M-East
Mahwah, NJ 07430
Ref. PFA 3554908 Please add the tracking number
Please assist us in meeting our regulatory obligation by completing and emailing the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site.
If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
Open, ClassifiedPosted Oct 7, 2024·Initiated Sep 9, 2024
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reason: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Root cause: Under Investigation by firm
Recalling firm: Atrium Medical CorporationType: Iliac Covered Stent, ArterialDistribution: US Nationwide distribution in the states of FL, MA, MI, OH, WA.Recall #Z-0024-2025
Open, ClassifiedPosted Oct 7, 2024·Initiated Apr 18, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason: When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution.
Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.Recall #Z-0025-2025
Open, ClassifiedPosted Oct 4, 2024·Initiated Jun 14, 2023
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:
1) IntelliVue MX400 866060;
2) IntelliVue MX450 866062;
3) IntelliVue MX500 866064;
4) IntelliVue MX550 866066
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Reason: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these
devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Root cause: Process control
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Foreign Only:
Denmark
France
Germany
Japan
United KingdomRecall #Z-0020-2025 Open, ClassifiedPosted Oct 3, 2024·Initiated Jul 31, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;
MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Reason: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing , Threshold SuspendDistribution: US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR.
OUS: WorldwideRecall #Z-0001-2025 Open, ClassifiedPosted Oct 3, 2024·Initiated Jul 31, 2024
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750;
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;
MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752;
MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868
MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862
Reason: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorDistribution: US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR.
OUS: WorldwideRecall #Z-0002-2025 Open, ClassifiedPosted Oct 3, 2024·Initiated Jul 31, 2024
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;
MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;
MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
Reason: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing Device System, Single Hormonal ControlDistribution: US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR.
OUS: WorldwideRecall #Z-0003-2025 Open, ClassifiedPosted Oct 3, 2024·Initiated Aug 12, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1.
Intended use: to prepare human specimens to be analyzed.
Reason: Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
Root cause: Software change control
Recalling firm: Becton, Dickinson and Company, BD Bio SciencesType: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisDistribution: US: NJ, UT, WI, TX, ID, AK, MN, MA, MD, TN, MI, CA, VA
OUS: Ireland, Austria, Italy, Germany, Belgium, Finland, Canada, France, Spain, New Zealand, United Kingdom, Japan, Australia, Norway, Singapore, Sweden, Turkey, Brazil, Colombia, Netherlands, United Arab Emirates, Saudi Arabia, Mexico, Switzerland, Costa Rica, China, Azerbaijan, Algeria, Jordan, IndiaRecall #Z-0009-2025
Open, ClassifiedPosted Oct 3, 2024·Initiated Aug 1, 2024
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Reason: Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
Root cause: Nonconforming Material/Component
Recalling firm: Outset Medical, Inc.Type: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND.
OUS: UAERecall #Z-0019-2025
Open, ClassifiedPosted Oct 2, 2024·Initiated Aug 30, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Reason: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Root cause: Process control
Recalling firm: Mercury Enterprises, Inc. dba Mercury MedicalType: Ventilator, Emergency, Powered (Resuscitator)Distribution: US distribution to MI, FL, SC, PA, IN. International distribution to Albania.Recall #Z-0004-2025
Open, ClassifiedPosted Oct 1, 2024·Initiated Aug 20, 2024
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Reason: Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Root cause: Nonconforming Material/Component
Recalling firm: Ossur H / FType: Orthosis, CervicalDistribution: US: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO, CO, UT, AZ, WA, OR, CA, NM, VA, IA, MN, NE, SC, MT, LA, ID, SD, AL, CT, OK, AK, PRRecall #Z-0006-2025
Open, ClassifiedPosted Oct 1, 2024·Initiated Jan 18, 2023
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Reason: The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: Detector And Alarm, ArrhythmiaDistribution: US Nationwide. Global Distribution.Recall #Z-0007-2025
Open, ClassifiedPosted Oct 1, 2024·Initiated Aug 23, 2024
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Reason: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Root cause: Material/Component Contamination
Recalling firm: Young Dental Manufacturing I, LLCType: Cleaner, Ultrasonic, Medical InstrumentDistribution: Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.Recall #Z-0008-2025