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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Sep 26, 2023 SENTIERO Screening2, mobile medical devices for hearing examinations, Model N... Affected lots of product may experience technical distortions to a greater extent than expected. Class II PATH
Sep 26, 2023 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 RAPIDPOINT 500e Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... Class II Siemens Healthcare Diagnostics Inc
Sep 26, 2023 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized... 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 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH10... Affected lots of product may experience technical distortions to a greater extent than expected. Class II PATH
Sep 26, 2023 Grafton DBM Crunch, Model Numbers: T44115, 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 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 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 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 Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d)... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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 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 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 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 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

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.