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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Apr 9, 2025 PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acousti... The high voltage capacitor may fail early in the product life cycle after delivery of surge volta... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Jun 25, 2021 CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 Product labeled as Cutting Electrode may contain BIVAP electrode. Class II Richard Wolf GmbH
Jun 5, 2020 Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) com... Tube material of a smaller diameter was used. Class II Richard Wolf GmbH
Oct 17, 2018 Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ... There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally rel... Class II Richard Wolf GmbH
Mar 11, 2018 RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endosc... Tube ends may be mixed up. Class II Richard Wolf GmbH
Jul 24, 2017 Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cart... Punch may have a burr in one section of the joint and when the punch is open, there is an increas... Class II Richard Wolf GmbH

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.