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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
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
May 31, 2017 BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: Thes... Hub damage resulting in breakage and/or leakage during use. Class II Becton Dickinson & Company
May 25, 2017 BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalo... Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7m... Class II Becton Dickinson & Company
May 23, 2017 Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to... Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... Class II Pentax of America Inc
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended t... Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... Class II Pentax of America Inc
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 22, 2017 Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 70106... 55 kits were distributed after their expiration date of September 2015. Class II Maquet
May 22, 2017 PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Nu... Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump ... Class II Flowonix Medical, Inc.
Apr 28, 2017 TI Transport Monitor/Module Battery Pack Product Usage: intended for moni... Mindray has received two reports from outside the United States that the battery pack for TI tran... Class II Mindray DS USA, Inc. dba Mindray North America
Apr 26, 2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-4... Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport... Class II Stryker Howmedica Osteonics Corp.
Apr 24, 2017 Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. Class II Konica Minolta, Inc.
Apr 19, 2017 Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps ar... There is a material mislabeling of the AFN End Cap. Class II Ortho Solutions Inc
Apr 13, 2017 Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-... There is a potential for the gel packets to have leaks in the packet seal. Class II Parker Laboratories, Inc.
Apr 13, 2017 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used t... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to el... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronicall... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 12, 2017 SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & ... Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION ... Class II Datascope Corporation
Mar 16, 2017 BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, ... BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrat... Class II Becton Dickinson & Company
Mar 3, 2017 Panta Nail, Rx only, Sterile, Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the ... Class II Integra LifeSciences Corp.
Feb 17, 2017 Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscop... Fujifilm is recalling multiple endoscopes after a retrospective review. Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 16, 2017 Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Numbe... A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was a... Class II Datascope Corporation
Feb 2, 2017 Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gx... The stopcock was found to have punctures. Class II Elcam Medical, Inc.
Jan 27, 2017 VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usag... Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the d... Class II Maquet Cardiovascular, LLC
Jan 27, 2017 BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Bl... After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of... Class II Becton Dickinson & Company
Jan 25, 2017 The UNI-CP System; Model Number: 330230SND. The firm received one complaint from one non-US sales representative (France) that the label on t... Class III Integra LifeSciences Corp.
Jan 20, 2017 Integra Cadence Total Ankle System Posterior tibial fractures have been reported. Class II Integra LifeSciences Corp.
Jan 17, 2017 Video Duodenoscope These instruments are intended to provide optical visua... Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope t... Class II Pentax of America Inc
Jan 16, 2017 BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x... A portion of this lot of blood collection tubes was manufactured with approximately twice the exp... Class II Becton Dickinson & Company
Dec 23, 2016 CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09... Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 23, 2016 BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... Class II Becton Dickinson & Company
Dec 20, 2016 Eclipse Hypodermic Needle BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaint... Class II Becton Dickinson & Company
Dec 12, 2016 Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9... Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngost... Class II Pentax of America Inc
Dec 2, 2016 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound... Reunion TSA Peg Alignment Sound broke during surgery. Class II Stryker Howmedica Osteonics Corp.
Nov 22, 2016 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the... Class II Reckitt Benckiser LLC
Nov 16, 2016 LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time R... The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 079... Class II Roche Molecular Systems, 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.