Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-03-04FDA-DeviceRemel, IncClass IIStop using Remel Campy CVA Medium lot R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- 2026-03-04FDA-DeviceMedtronic Perfusion SystemsClass IICheck Medtronic Octopus Nuvo Tissue Stabilizer lot 0232837110
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- 2026-03-04FDA-DeviceAgiliti Health - EllisClass IICheck your Agiliti Adapt Pump settings
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIStop using Medline dialysis dressing change kits
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIStop using recalled dialysis dressing kits
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline dialysis kits
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIStop using Medline dialysis on/off kits (SKU EBSI1746)
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline dialysis kits
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- 2026-03-04FDA-DeviceEdermy LLCClass IIStop using Edermy PIE PAK devices
Lack of 510K clearance
- 2026-03-04FDA-DeviceEdermy LLCClass IIStop using Edermy PIE Trolley System Model 2005
Lack of 510K clearance
- 2026-03-04FDA-DeviceEncore Medical, LPClass IICheck your Encore Medical shoulder implant labeling
Knee and Humeral socket implants contain incorrect labeling.
- 2026-03-04FDA-DeviceEncore Medical, LPClass IICheck Encore Medical knee implant labeling
Knee and Humeral socket implants contain incorrect labeling.
- 2026-03-04FDA-DeviceEncore Medical, LPClass IICheck reverse shoulder implant labeling
Knee and Humeral socket implants contain incorrect labeling.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath A2666T
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Inner Sheath Model A2642
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Inner Sheath Model A2641
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Model A37004A sheaths
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIContact Olympus about recalled urological sheath
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus resection sheath Model A2666
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus WA22017T inner sheath
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Inner Sheath WA22017A
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Inner Sheath Model A4741
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath Model A42011A
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Inner Sheath Model A2660
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath A22043T
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath 28 Fr.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath A22042T
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath Model A22042A
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Resection Sheath Model A22041T
Complaints of the ceramic tip of the resection sheath breaking have been received.
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