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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.