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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Date	Product	Reason	Class	Firm
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
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

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.