Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 17, 2021 Change Healthcare Enterprise Viewer Change Healthcare has identified an intermittent software defect which may result in an anchor st... Class II CHANGE HEALTHCARE CANADA COMPANY
Mar 4, 2021 Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with... The spreader bar can disconnect from the scale bottom attachment. Class II Arjohuntleigh Magog, Inc.
Mar 3, 2021 RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information s... Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCa... Class II RAYSEARCH LABORATORIES AB
Mar 1, 2021 MyWay Walker Chassis - Product Usage: is intended for use by children already... Due to a failure of the welds, the casters detached from the rear legs of the walker. Class II James Leckey Design Ltd
Feb 24, 2021 Philips CT systems are advanced continuous-rotation computed tomography syste... Philips has internally detected an issue with the actuators used in the Incisive CT couch, which ... Class II Philips Healthcare (Suzhou) Co., Ltd.
Feb 22, 2021 RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... Class II RAYSEARCH LABORATORIES AB
Feb 22, 2021 SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for s... There is a potential presence of particulate matter in the D-Vial. Class II Sirtex Medical Limited
Feb 11, 2021 Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Ref... Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of th... Class II Imactis
Feb 9, 2021 In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot m... This Field Action is being conducted following identification of manufacturing non-conformity of ... Class II In2Bones, SAS
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 13, 2021 Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), R... There potential that electromagnetic fields generated in the therapy system may cause technical d... Class II BEMER INT. AG
Jan 12, 2021 Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: in... The external drainage system failed to meet Pyrogen test requirements for devices contacting cere... Class II Natus Manufacturing Limited
Jan 4, 2021 NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Produ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage:... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage:... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage:... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used w... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usag... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used wi... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with e... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with e... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with e... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with e... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used wit... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.

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.