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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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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Dec 14, 2017 Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is w... Torn sheath liner material was detected at the proximal end of the device during internal product... Class II Kalila Medical
Dec 11, 2017 smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... Class II Smith & Nephew, Inc.
Dec 11, 2017 smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... Class II Smith & Nephew, Inc.
Dec 8, 2017 ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A... There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... Class II Abbott Laboratories, Inc
Dec 8, 2017 Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revisi... Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... Class II Zimmer Biomet, Inc.
Dec 8, 2017 ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... Class II Abbott Laboratories, Inc
Dec 8, 2017 Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revisi... Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... Class II Zimmer Biomet, Inc.
Dec 8, 2017 ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... Class II Abbott Laboratories, Inc
Dec 7, 2017 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887... One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated scr... Class II Zimmer Biomet, Inc.
Dec 7, 2017 Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... Some of the cards show occasional shorter clot times than the expected variation resulting in a p... Class II Helena Laboratories, Corp.
Dec 4, 2017 Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Dec 4, 2017 Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461;... The Oncomine Dx Target Test may report erroneous results when used off-label for samples other th... Class II Life Technologies Corporation
Dec 4, 2017 PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Dec 1, 2017 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. Class II Stryker Sustainability Solutions
Dec 1, 2017 RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... Incorrect product and/or label. Sizing is labeled incorrectly. Class II Mako Surgical Corporation
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 28, 2017 The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen... The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i... Class II DePuy Orthopaedics, Inc.
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF ... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 24, 2017 U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Nov 24, 2017 U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Nov 22, 2017 ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use ... An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number ... Class II Atrium Medical Corporation
Nov 22, 2017 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyuretha... The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked ... Class II Medical Components, Inc dba MedComp
Nov 22, 2017 CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... Class II Smiths Medical ASD Inc.
Nov 21, 2017 OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... The device software versions have an anomaly which may produce an erroneous marking for the quali... Class II Oculus Optikgeraete GMBH
Nov 17, 2017 StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II CareFusion 303, Inc.
Nov 17, 2017 ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II CareFusion 303, Inc.
Nov 17, 2017 STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 14, 2017 Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591... The recalled lots have demonstrated unexpected false positive THC results. Class II Alere San Diego, Inc.
Nov 10, 2017 iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca... iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc... Class II Beckman Coulter Inc.
Nov 10, 2017 NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag... Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme... Class II NxStage Medical, Inc.
Nov 6, 2017 Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ... Stent possibly unable to be fully released from the delivery system. Class II Boston Scientific Corporation
Nov 6, 2017 Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be ... Scalpels lot contains non-sterile products labeled as sterile. Class II Southmedic, Inc.
Nov 6, 2017 Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and... Stent possibly unable to be fully released from the delivery system. Class II Boston Scientific Corporation
Nov 3, 2017 Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... Stent length on the label may not match the length of the stent itself. Class II Medtronic Inc.
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Nov 3, 2017 Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Nov 3, 2017 First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c... Affected lots may have exceeded its microbial limits. Class II Madison Polymeric Engineering
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Nov 2, 2017 CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. Product may have incorrect cation information detailed on the product label. Class II Remel Inc
Oct 26, 2017 Arterial Access Tray, introducer catheter; Model: GU-04020 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc

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.