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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

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

Clear
DateProductReasonClassFirm
May 24, 2023 Power-PRO 2- A powered ambulance cot that consists of a platform, including a... Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... Class II Stryker Medical Division of Stryker Corporation
May 24, 2023 NeuMoDx Cartridge-used for extraction, purification, amplification and detect... Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... Class II NeuMoDx Molecular Inc
May 24, 2023 RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... DNAs used during the manufacture of two affected models were accidentally inverted during manufac... Class II Cytocell Ltd.
May 23, 2023 BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varni... Class II Young Dental Manufacturing I, LLC
May 23, 2023 SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 wDR 2.2 Mobile Digital Diagnostic X-Ray System There is a software login in issue that may prevent the user from logging in. Class II SEDECAL SA
May 23, 2023 SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2023 PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 22, 2023 PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... Class II Covidien, LLC
May 22, 2023 PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... Class II CareFusion 303, Inc.
May 22, 2023 HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 22, 2023 One Step Ovulation Test REF 200-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility LH Ovulation Test (Strip) REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS Ovulation Predictor Midstream REF 200-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" UTI Test Strips REF 900-UTI Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test S... Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 One Step Pregnancy Test REF 100-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility hCG Pregnancy Urine Test REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech 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.