Browse Device Recalls

415 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 415 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 415 FDA device recalls.

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DateProductReasonClassFirm
Oct 16, 2020 Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: use... A new inspection step was added to the cleaning and disinfection section of the Instructions For ... Class II Olympus Corporation of the Americas
Oct 16, 2020 Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: us... A new inspection step was added to the cleaning and disinfection section of the Instructions For ... Class II Olympus Corporation of the Americas
Oct 16, 2020 Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: u... A new inspection step was added to the cleaning and disinfection section of the Instructions For ... Class II Olympus Corporation of the Americas
Aug 31, 2020 Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to b... The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associate... Class II Olympus Corporation of the Americas
Aug 31, 2020 Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Ol... The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the d... Class II Olympus Corporation of the Americas
Jul 14, 2020 Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
Jul 14, 2020 Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
May 5, 2020 ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within... Products repaired with the incorrect service manual may be missing an O ring and are subject to r... Class II Olympus Corporation of the Americas
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

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.