Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Sep 26, 2023	Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone M...	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp...	Class II	Medtronic Sofamor Danek USA Inc
Sep 26, 2023	SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Nu...	Affected lots of product may experience technical distortions to a greater extent than expected.	Class II	PATH
Sep 26, 2023	Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp...	Class II	Medtronic Sofamor Danek USA Inc
Sep 25, 2023	Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 25, 2023	Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Mobile airway scope-diagnosis and observation to access airway anatomy, endot...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Small intestinal videoscope-For endoscopy and endoscopic surgery within the u...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-5936...	Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles...	Class II	Securitas Healthcare LLC
Sep 25, 2023	Gastrointestinal videoscope-indicated for use within the upper digestive trac...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Tracheal videoscope- For airway management, which includes observation to acc...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; ...	Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles...	Class II	Securitas Healthcare LLC
Sep 25, 2023	Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Insufflation unit, UHI-4.	Olympus has become aware of an increased trend of both repairs and customer complaints reporting ...	Class II	Olympus Corporation of the Americas
Sep 25, 2023	RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 25, 2023	Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Colonoscope-indicated for use within the lower digestive tract (including the...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class III	Aizu Olympus Co., Ltd.
Sep 25, 2023	Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59...	Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles...	Class II	Securitas Healthcare LLC
Sep 25, 2023	Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Tracheal fiberscope-airway management, which includes observation to access a...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 23, 2023	SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Refe...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 23, 2023	CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref ...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 23, 2023	SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) n...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 22, 2023	DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall...	Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ...	Class II	Musculoskeletal Transplant Foundation, Inc.
Sep 22, 2023	Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.	There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur...	Class I	Olympus Corporation of the Americas
Sep 21, 2023	DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated ...	Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.	Class II	Atrium Medical Corporation
Sep 21, 2023	EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	DigitalDiagnost C90 High Performance, used to acquire, process, store, displa...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ...	When using affected curette and software, there is a discrepancy between the actual curette tip l...	Class II	Acclarent, Inc.
Sep 21, 2023	8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ...	Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In...	Class I	B. Braun Medical, Inc.
Sep 21, 2023	DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular conveni...	Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Ins...	Class II	ROi CPS LLC
Sep 21, 2023	8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System	Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In...	Class I	B. Braun Medical, Inc.
Sep 21, 2023	DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	DigitalDiagnost 4 High Performance, used to acquire, process, store, display ...	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc
Sep 21, 2023	CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system	Potential for units suspended on the ceiling to fail and fall.	Class II	Philips North America Llc

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.