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Browse Device Recalls

23 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 23 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 23 FDA device recalls.

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DateProductReasonClassFirm
Jan 15, 2026 Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM ... There is the potential for the length of the trocar shaft to be too long. Class II Aesculap Inc
Sep 24, 2025 Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig ... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover A... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Art... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf ... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus To... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
May 13, 2024 Aeos Robotic Digital Microscope, Product Code: PV010 Possibility of the robotic arm to drop more than 10cm from its original position after pressing t... Class II Aesculap Inc
Jan 9, 2024 DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Dec 29, 2023 MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... Class II Aesculap Inc
Dec 29, 2023 MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... Class II Aesculap Inc
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 11, 2014 Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... Class III Aesculap, Inc.
Oct 24, 2014 The Dual Switch Valve is used for fluid drainage from the ventricles into the... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to i... Class II Aesculap, Inc.
Jun 13, 2014 Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... Class II Aesculap, Inc.
Apr 21, 2014 Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... Class II Aesculap, Inc.

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.