Open, ClassifiedPosted Jul 9, 2026·Initiated Jun 4, 2026
VITEK 2 AST-N447 TEST KIT
Product reference 424620
Reason: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Root cause: Process change control
Recalling firm: Biomerieux IncType: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: International distribution to the countries of Belgium and the Netherlands.Recall #Z-2715-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated May 8, 2026
TMINI Femur Tracking Array REF 109003
UDI-DI code: M9461090030
TMINI Tibia Tracking Array REF 109004
UDI-DI code: M9461090040
TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
Reason: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Root cause: Process control
Recalling firm: Think Surgical, Inc.Type: Orthopedic Stereotaxic InstrumentDistribution: U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.Recall #Z-2716-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated Jun 9, 2026
Brand Name: Versius Surgical System US
Product Name: Vesius Surgeon Console US
Model/Catalog Number: V-SS-1020
Software Version: Pratchett 1 version 62.1
Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system
designed for surgeons to perform minimally invasive surgery.
Reason: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Root cause: Software design (manufacturing process)
Recalling firm: CMR SURGICAL LIMITEDType: Modular Electromechanical Surgical SystemDistribution: US Nationwide distribution in the state of California.Recall #Z-2717-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated Apr 22, 2026
Intracept Access Instruments, Description/REF:
INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035,
INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU,
INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045,
INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU,
INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055,
INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU,
INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065,
INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075,
INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU
Reason: Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Root cause: Packaging process control
Recalling firm: Boston Scientific Neuromodulation CorporationType: Probe, Radiofrequency LesionDistribution: Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.Recall #Z-2694-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated May 28, 2026
Medline Convenience Kits:
1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Reason: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US Nationwide distribution.Recall #Z-2695-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated May 28, 2026
Medline Convenience Kits:
1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;
2) ACCESSORY KIT, Model Number: DYNJ901348F
Reason: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution.Recall #Z-2696-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated May 28, 2026
Medline Convenience Kits:
1) OPEN HEART PEDS PACK, Model Number: DYNJ88569;
2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A;
3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B;
4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
Reason: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution.Recall #Z-2697-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated May 27, 2026
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Reason: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
Root cause: Software design
Recalling firm: Medtronic MiniMed, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: International distribution to the countries of Spain, Great Britain, Netherlands, Italy.Recall #Z-2698-2026 Open, ClassifiedPosted Jul 8, 2026·Initiated Jun 8, 2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Reason: A product error defect may cause incorrect bracket placement.
Root cause: Process control
Recalling firm: Klowen BracesType: Indirect Bonding TrayDistribution: US Nationwide distribution in the states of OH, TX, SC VA.Recall #Z-2699-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated Feb 16, 2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
Reason: Due to packaging discrepancy with incorrect product size mixed up.
Root cause: Process change control
Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
NE190 Implant Medical Sales, Inc. New York (NY)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
SE180 Joint Medical Solutions, L.L.C. Alabama (AL)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
GL108 Great Lakes Medical Illiniois (IL)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1
CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2
MA102 ProCore Medical LLC - NC North Carolina (NC)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
Total 11Recall #Z-2700-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated Feb 16, 2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Reason: Due to packaging discrepancy with incorrect product size mixed up.
Root cause: Process change control
Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
NE190 Implant Medical Sales, Inc. New York (NY)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
SE180 Joint Medical Solutions, L.L.C. Alabama (AL)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
GL108 Great Lakes Medical Illiniois (IL)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1
CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2
MA102 ProCore Medical LLC - NC North Carolina (NC)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
Total 11Recall #Z-2701-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated May 11, 2026
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions.
1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6.
2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1.
3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3.
4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C.
5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Reason: Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Root cause: Process control
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.Recall #Z-2702-2026
Open, ClassifiedPosted Jul 8, 2026·Initiated Jun 8, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Reason: The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Hemoglobin A1c Test SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.Recall #Z-2703-2026 Open, ClassifiedPosted Jul 7, 2026·Initiated Jun 5, 2026
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Reason: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Duodenoscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-2676-2026
Open, ClassifiedPosted Jul 7, 2026·Initiated Jun 8, 2026
Aquacel Ag Surgical SP
REF: 413556
9cm x 15cm/3.5 in. x 6 in., Sterile R
Reason: Surgical dressing manufactured out of specification (greater thickness).
Root cause: Nonconforming Material/Component
Recalling firm: ConvaTec, IncType: Dressing, Wound, DrugDistribution: US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.Recall #Z-2677-2026
Open, ClassifiedPosted Jul 2, 2026·Initiated May 15, 2026
Reprocessed Electrophysiology Catheters and Ultrasound Catheters
Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;
Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Reason: Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide distribution in the state of TX.Recall #Z-2615-2026
Open, ClassifiedPosted Jul 2, 2026·Initiated May 22, 2026
Medtronic Harmony Delivery Catheter System
Reason: Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Root cause: Process control
Recalling firm: Medtronic Heart Valves DivisionType: Pulmonary Valve Prosthesis Percutaneously DeliveredDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.Recall #Z-2624-2026
Open, ClassifiedPosted Jul 2, 2026·Initiated Apr 23, 2026
Covidien Shiley Disposable Decannulation Plug
REF
DDCP
UDI-DI code: 10884522004060
Product Codes that include the Covidien Shiley Disposable Decannulation Plug are:
Product Number / UDI-DI code
4DCFN 10884522006576
4DCFS 10884522006583
4DFEN 10884522006606
6DCFN 10884522006613
6DCFS 10884522006620
6DFEN 10884522006644
8DCFN 10884522006651
8DCFS 40884522006690
8DFEN 10884522006675
10DCFN 20884522006535
10DCFS 10884522006545
10DFEN 10884522006569
The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.
Reason: Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Root cause: Labeling Change Control
Recalling firm: Covidien LLCType: Tube, Tracheostomy (W/Wo Connector)Distribution: U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The countries of Albania, Andorra, Argentina, Australia, Austria, Belgium, Bhutan, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guyana, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lithuania, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Togo, Trinidad And Tobago, Turkey, Uganda, United Arab Emirates, Uruguay.Recall #Z-2653-2026
Open, ClassifiedPosted Jul 2, 2026·Initiated Jun 4, 2026
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555
Catalog Number: SAM2461
UDI code: N/A
Engineering Sample/Not for Human Use
Reason: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Root cause: Under Investigation by firm
Recalling firm: BD SWITZERLAND SARLType: Set, Administration, IntravascularDistribution: U.S.: IL
O.U.S: N/ARecall #Z-2654-2026
Open, ClassifiedPosted Jul 2, 2026·Initiated May 21, 2026
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED
UDI-DI Code: 0110885403284748
PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM
UDI-DI Code: 0110885403108365
TPT1000 THORACENTESIS/PARACENTESIS TRAY
UDI-DI Code: 0110885403108488
The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Root cause: Nonconforming Material/Component
Recalling firm: Bard Access Systems, Inc.Type: Thoracentesis TrayDistribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.Recall #Z-2655-2026