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