Browse Device Recalls

389 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 389 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 389 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 8, 2018 Bronchofiberscope BF-P40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-P180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-MP160F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-3C40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-P60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-1T60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Airway Mobilescope MAF-TM The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-XT40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-XP60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-XP40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-Q180-AC The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-Q180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofibercope BF-6C240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-XT160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-P240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope F-1TQ180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope F-1T160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Ultrasonic Bronchoscope BF-UC160F-OL8 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Rhino Laryngo scope ENF-VT2 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-XP160F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
May 11, 2018 Olympus JF-160F duodenoscopes (Model NumberJF-160F) Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additiona... Class II Olympus Corporation of the Americas
May 11, 2018 Olympus JF-140F duodenoscopes (Model NumberJF-140F) Issuance of validated, new reprocessing procedures. This corrective action is being undertaken ... Class II Olympus Corporation of the Americas
Jan 17, 2018 Uretero-reno fiberscope URF-P6 Breakage of the endoscope's insertion tube bending section during surgical procedures. Class II Olympus Corporation of the Americas
Jan 17, 2018 Uretero-reno fiberscope URF-P6RP6 Breakage of the endoscope's insertion tube bending section during surgical procedures. Class II Olympus Corporation of the Americas
Jan 17, 2018 Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R Potential breakage of the endoscope s insertion tube bending section during surgical procedures Class II Olympus Corporation of the Americas
Aug 18, 2017 A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bri... Olympus has received complaints about fragments of adhesive which detached from inside the workin... Class II Olympus Corporation of the Americas
Apr 19, 2017 High Frequency Resection Electrodes, endoscope, ac-powered and accessories T... Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. Class II Olympus Corporation of the Americas
Feb 10, 2017 Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 m... A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to becom... Class II Olympus Corporation of the Americas
Dec 12, 2016 URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) bu... Class II Olympus Corporation of the Americas
Dec 12, 2016 Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The U... Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending ... Class II Olympus Corporation of the Americas
Nov 3, 2016 HF Cable WA00014A, Endoscopic electrosurgical unit and accessories Software malfunction that results in incorrect generation or display of error codes. Class II Olympus Corporation of the Americas
Jun 23, 2016 OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when usi... Class II Olympus Corporation of the Americas
Mar 15, 2016 EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus v... New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised man... Class II Olympus Corporation of the Americas
Jan 8, 2016 Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: T... Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenos... Class II Olympus Corporation of the Americas
Nov 17, 2015 Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm... A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. E... Class II Olympus Corporation of the Americas
Sep 11, 2015 MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a con... small puncture marks in a sterile package for an accessory to an Olympus device Class II Olympus Corporation of the Americas
Aug 21, 2015 EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscop... Insufficient information for specific cleaning accessories used for the cleaning and reprocessing... Class II Olympus Corporation of the Americas

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.