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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

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Nov 17, 2015 BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Us... Some tubes were manufactured with the stopper not fully inserted into the tube. This may result i... Class II Becton Dickinson & Company
Nov 17, 2015 ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in... The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr... Class III Collagen Matrix Inc
Nov 13, 2015 Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W ... Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% vol... Class II Maquet Cardiovascular Us Sales, Llc
Oct 15, 2015 Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmed... Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the U... Class II Stryker Howmedica Osteonics Corp.
Sep 29, 2015 Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, R... Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints w... Class II Stryker Howmedica Osteonics Corp.
Sep 25, 2015 Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to p... Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because... Class II Stryker Spine
Sep 24, 2015 Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #W... Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A... Class II Airways Development LLC
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants... Class II Stryker Howmedica Osteonics Corp.
Sep 21, 2015 Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator,... The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is ... Class II Valeant Pharmacueticals International
Sep 14, 2015 Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size A... SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per qual... Class II Valeant Pharmaceuticals North America LLC
Sep 8, 2015 Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine... The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated... Class II Stryker Spine
Sep 8, 2015 Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis... Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion ... Class II Stryker Howmedica Osteonics Corp.
Aug 31, 2015 Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED... A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed el... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 25, 2015 NuOSS Cancellous Intended for use in dental surgery. On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous produ... Class II Collagen Matrix Inc
Aug 21, 2015 Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Univer... Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to t... Class II Integra LifeSciences Corp.
Aug 17, 2015 Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacture... Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... Class II Maquet Cardiovascular Us Sales, Llc
Aug 17, 2015 Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Ma... Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... Class II Maquet Cardiovascular Us Sales, Llc
Jul 27, 2015 Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detec... The DPM 7 Monitors may display a black screen. Class II Mindray DS USA, Inc. dba Mindray North America
Jul 24, 2015 cobas Liat Analyzer, for in vitro diagnostic use. Due to a supplier issue, the incorrect green and amber LED components were used in the manufactur... Class II Roche Molecular Systems, Inc.
Jul 19, 2015 Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVL... Punctured blister packages were detected during the packaging process at the manufacturing site. ... Class II Elcam Medical, Inc.
Jul 19, 2015 Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring... Punctured blister packages were detected during the packaging process at the manufacturing site. ... Class II Elcam Medical, Inc.
Jul 14, 2015 Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD... Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking th... Class II Ortho Solutions Inc
Jun 30, 2015 Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic ... The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 30, 2015 Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, E... The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position fol... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 30, 2015 Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For... The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 25, 2015 Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant compo... it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, wa... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2015 BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. ... Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifi... Class III Becton Dickinson & Company
Jun 15, 2015 i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ... Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs p... Class II Abbott Point Of Care Inc.
Jun 10, 2015 Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Ar... There is a potential issue that could result to collision between the C-arm of the angiography sy... Class II Maquet Cardiovascular Us Sales, Llc
May 29, 2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size ... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light syst... Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the j... Class II Maquet Cardiovascular Us Sales, Llc
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... Class II Stryker Howmedica Osteonics Corp.
May 27, 2015 Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt ... Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because t... Class II Integra LifeSciences Corp.
May 27, 2015 Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical... Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits becaus... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do ... Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins... Class II Musculoskeletal Transplant Foundation, Inc.
May 15, 2015 Cell Search Circulating Tumor Kit. Intended for the enumeration of circulatin... Complaints of the presence of artifacts that appears as small bead like structures in the image g... Class II Veridex, LLC
May 12, 2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part... Class II Stryker Howmedica Osteonics Corp.
May 8, 2015 Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Sur... Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the ... Class II Ethicon, Inc.
Apr 14, 2015 The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... Class II Integra LifeSciences Corp.
Apr 14, 2015 The Integra Camino ICP Monitor is a compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 M... Class II Integra LifeSciences Corp.
Apr 14, 2015 The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... Class II Integra LifeSciences Corp.
Apr 2, 2015 FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ... In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas l... Class I Maquet Cardiovascular Us Sales, Llc
Mar 13, 2015 Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile dev... A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 w... Class II Integra LifeSciences Corp.
Mar 12, 2015 Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxia... Multiaxial screws may not meet internal requirements related to fatigue strength. Compression te... Class II Biomet Spine, LLC
Mar 12, 2015 Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ... Class II Mindray DS USA, Inc. dba Mindray North America

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.