Browse Device Recalls

407 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 407 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 407 FDA device recalls.

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DateProductReasonClassFirm
Apr 23, 2020 OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material th... Class II Olympus Corporation of the Americas
Mar 23, 2020 Olympus Pleuravideoscope, Model LTF-240 There was no data to validate that the identified endo-therapy devices were compatible with certa... Class II Olympus Corporation of the Americas
Mar 23, 2020 Olympus Pleuravideoscope, Model LTF-160 There was no data to validate that the identified endo-therapy devices were compatible with certa... Class II Olympus Corporation of the Americas
Sep 12, 2019 Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Pr... Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-ha... Class II Olympus Corporation of the Americas
Jun 10, 2019 Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Mo... WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounte... Class II Olympus Corporation of the Americas
Apr 1, 2019 Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Us... There is a potential for the single use suction valve to come apart and/or remain stuck inside th... Class II Olympus Corporation of the Americas
Dec 17, 2018 Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscop... The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... Class II Olympus Corporation of the Americas
Dec 17, 2018 Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscop... The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... Class II Olympus Corporation of the Americas
Dec 17, 2018 Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended... The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... Class II Olympus Corporation of the Americas
Dec 17, 2018 Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are in... The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-3C160 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-P160 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 Bronchovidescope BF-1T240 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-1T40 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-40 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-1T180 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-MP60 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-UC180F 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-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

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.