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.

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DateProductReasonClassFirm
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.