Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

Clear
DateProductReasonClassFirm
Apr 12, 2021 DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00... failed rivet at the chafe tab of arm sling. Class II DJ Orthopedics de Mexico S.A. de C.V.
Apr 9, 2021 PERLA TL Lateral Connector Open - Product Usage: intended to be used with aut... Due to external labelling error/mix-up. Affected product external labels list the incorrect rod ... Class II SPINEART SA
Apr 8, 2021 Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2,... The supplier informed them of possible deviations of the parameters/processes defined for ethylen... Class II Spes Medica
Apr 8, 2021 SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating... The supplier informed them of possible deviations of the parameters/processes defined for ethylen... Class II Spes Medica
Apr 8, 2021 Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. ... The supplier informed them of possible deviations of the parameters/processes defined for ethylen... Class II Spes Medica
Apr 8, 2021 Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1... The supplier informed them of possible deviations of the parameters/processes defined for ethylen... Class II Spes Medica
Apr 8, 2021 SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating... The supplier informed them of possible deviations of the parameters/processes defined for ethylen... Class II Spes Medica
Apr 7, 2021 RayStation standalone software radiation therapy treatment planning system. ... When using more than one plan in a treatment course, the Total dose display in Dose tracking ma... Class II RAYSEARCH LABORATORIES AB
Apr 1, 2021 DirectInject consists of a sterile dual paste system which is calcium phospha... Inability for the user to inject the paste from the syringe into the target location. Class II Stryker Leibinger GmbH & Co. KG
Mar 30, 2021 Omnia Soft Tissue Punch is a dental instrument designed to remove with precis... Omnia SRL received a notification from the contract manufacturer informing them of inadequate ste... Class II Omnia SRL
Mar 26, 2021 PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to ... Class II Radiometer Medical ApS
Mar 25, 2021 RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.... Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. Class II RAYSEARCH LABORATORIES AB
Mar 22, 2021 Spectrum Medical Quantum Standard heat exchanger Product labeled as sterile may not have been adequately sterilized. In addition, these devices we... Class II QURA S.R.L.
Mar 22, 2021 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KV... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 1... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE DRILL, CODE INTVM-DRL Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 Normand Remisol Advance Data Manager is a software device that interfaces bet... Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions reg... Class II Normand-Info S.A.S.U.
Mar 22, 2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, RE... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement m... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 19, 2021 Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specif... Users may observe additional locus specific signals at 9q34. The device pack insert indicates the... Class II Cytocell Ltd.
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

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.