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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
May 10, 2021 NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA ... Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect va... Class II Randox Laboratories Ltd.
May 5, 2021 Omnera 400T Digital Radiographic System There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th... Class II Arcoma AB
May 5, 2021 Omnera 400A Digital Radiographic System There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th... Class II Arcoma AB
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 26, 2021 Concerto User Interface Software provided with the following systems: (1) ... If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not u... Class II Xstrahl Limited
Apr 23, 2021 Synaptive Trackable Suction Set Standard and Malleable Due to visible burrs/metal filings affixed along the suction tube inner perimeter. Class II Synaptive Medical Inc
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination b... Removing parts for safety reasons due to possible breakage. Class II Dentech Corp.
Apr 21, 2021 RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 ... Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after ... Class II RAYSEARCH LABORATORIES AB
Apr 12, 2021 DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 0... failed rivet at the chafe tab of arm sling. Class II DJ Orthopedics de Mexico S.A. de C.V.
Apr 12, 2021 DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)001904466735... failed rivet at the chafe tab of arm sling. Class II DJ Orthopedics de Mexico S.A. de C.V.
Apr 12, 2021 DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446... failed rivet at the chafe tab of arm sling. Class II DJ Orthopedics de Mexico S.A. de C.V.
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.

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.