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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 8, 2023 | Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | HF Resection Electrodes - HF resection electrodes are part of a resectoscope ... | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end... | Class II | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disi... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway managemen... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level di... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level dis... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 19, 2023 | UroPass Ureteral Access Sheaths, 5 pieces/box | Dilator tips may break in the package and in patients during surgical procedures. | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Nee... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histolog... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm O... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD,... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brus... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemosta... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemos... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemosta... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemos... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| Apr 18, 2023 | Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA II... | The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the end... | Class II | Olympus Corporation of the Americas |
| Mar 31, 2023 | To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Mar 31, 2023 | ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endo... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Feb 23, 2023 | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 16... | There have been complaints that the clip did not come out of the tube sheath during the procedure. | Class II | Olympus Corporation of the Americas |
| Dec 21, 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t... | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o... | Class II | Olympus Corporation of the Americas |
| Dec 13, 2022 | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-... | Class II | Olympus Corporation of the Americas |
| Nov 4, 2022 | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be c... | Class II | Olympus Corporation of the Americas |
| Sep 16, 2022 | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical a... | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of acces... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Jul 7, 2022 | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S | Mis-wired component-the improperly wired component can result in additional noise on the power su... | Class II | Olympus Corporation of the Americas |
| May 26, 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150... | Device model and size for affected lots of Laser Fibers may be mismatched between the product's c... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2022 | Colonovideoscope Model CF-H180AL | A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the ... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2022 | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper ... | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used ... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Mar 31, 2022 | Olympus DISPOSABLE GRASPING FORCEPS, FG-51D | Forceps do not comply with Olympus standards for the amount of force required to open and close t... | Class II | Olympus Corporation of the Americas |
| Mar 25, 2022 | Olympus Uretero-reno videoscope, Model No. URF-V2 | The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulatio... | Class II | Olympus Corporation of the Americas |
| Mar 18, 2022 | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time... | GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-1TQ180: EVIS EXERA II Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-MP60: OES Bronchofiberscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-MP160F: EVIS EXERA Bronchofibervideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-3C160: EVIS EXERA Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Dec 23, 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) | Class II | Olympus Corporation of the Americas |
| Dec 13, 2021 | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfecti... | The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If th... | 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.