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
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
Nov 2, 2021 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope cont... Class II Olympus Corporation of the Americas
Sep 21, 2021 ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoline... Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in ... Class II Olympus Corporation of the Americas
Aug 17, 2021 EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 A gluing step was not performed during the manufacturing of the affected device's insertion tube.... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-P60 OES Bronchofiberscope, Model No. BF-P60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-N20 OES Bronchofiberscope, Model No. BF-N20 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 3, 2021 Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number:... Packaging seal defect may allow a breach of the package sterile barrier and result in patient inf... Class II Olympus Corporation of the Americas
Jun 30, 2021 Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser ... Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded ... Class II Olympus Corporation of the Americas
Jun 9, 2021 Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, me... Expired adhesive used as an electrical insulation barrier and as a secondary retention bond faile... Class II Olympus Corporation of the Americas
Jan 28, 2021 Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Ol... Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated w... Class II Olympus Corporation of the Americas
Oct 16, 2020 Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used fo... 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-UCT140-AL5 - 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-UM130 - Product Usage: used wi... 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-UCT160-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-UCT180 - Product Usage: used w... 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-UMQ130 - Product Usage: used w... 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-UM20 - Product Usage: used wit... 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-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

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.