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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

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Apr 6, 2020 OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI ... The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... Class II Philips North America, LLC
Apr 6, 2020 OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Produ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... Class II Philips North America, LLC
Apr 6, 2020 SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 81384502101... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 81384502069... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 81384502008... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 8138450200... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 81384502034... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 81384502... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 3, 2020 Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 ImmersiveView software version 2.1 Product Usage: ImmersiveView is intend... Observed an internal repetitive software glitch in ImmersiveView. Class III Immersivetouch Inc
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 -... While transferring blood the needle may dislodged and remain in the tube stopper which may cause ... Class II C.A. Greiner & Sohne Gesellschaftmbh
Apr 3, 2020 Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... Class III Pega Medical Inc.
Apr 3, 2020 Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:... Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc ... Class II Skeletal Kinetics, Llc
Apr 3, 2020 Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and... Class II Philips North America, LLC
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 2, 2020 Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Numbe... After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... Class II Insulet Corporation
Apr 2, 2020 Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACC... In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Mo... Class II Abbott Laboratories
Apr 2, 2020 OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number ... After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... Class II Insulet Corporation
Apr 2, 2020 OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Us... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GT... During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) prod... Class II GE Healthcare, LLC
Apr 2, 2020 OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Pro... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 1, 2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Shipments were transported outside of the required refrigerated temperature conditions. Potential... Class II Howmedica Osteonics Corp.
Apr 1, 2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories

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.