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Browse Device Recalls

61 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 61 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 61 FDA device recalls.

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DateProductReasonClassFirm
Aug 10, 2017 NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega... The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the in... Class II Aesculap Implant Systems LLC
Mar 28, 2017 GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.D... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 7, 2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... Class II Aesculap Implant Systems LLC
Jan 9, 2017 GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories Generators may have a faulty component which could impact the proper functioning of the device. Class II Aesculap Implant Systems LLC
Oct 28, 2016 Gomco Circumcision Clamps with separate O-Ring Component: The device is packa... Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. Class II Aesculap Implant Systems LLC
Aug 1, 2016 Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture There is a potential for the needle to detach from the suture thread during surgery. If the need... Class II Aesculap Implant Systems LLC
Jul 25, 2012 Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, S... There is a possibility that the screw channel that holds the rod in place may be out of tolerance... Class II Aesculap Implant Systems LLC
Jul 12, 2012 Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree T... The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but ... Class II Aesculap Implant Systems LLC
Mar 7, 2012 S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision... Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput ... Class II Aesculap Implant Systems LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.