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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

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 19, 2023 Contour¿ next GEN Blood Glucose Monitoring System Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lo... Class II Ascensia Diabetes Care US, Inc.
May 19, 2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for... Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis... Class II Qiagen GmbH
May 19, 2023 NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... Class II Baxter Healthcare Corporation
May 19, 2023 Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Ce... Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... Class II Baxter Healthcare Corporation
May 19, 2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not ... Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis... Class II Qiagen GmbH
May 19, 2023 NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class II Zimmer, Inc.
May 19, 2023 UroPass Ureteral Access Sheaths, 5 pieces/box Dilator tips may break in the package and in patients during surgical procedures. Class II Olympus Corporation of the Americas
May 19, 2023 DigitalDiagnost C90, Model No. 712034 and 712035 There is a software login in issue that may prevent the user from logging in. Class II Philips North America Llc
May 19, 2023 Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 20... GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h... Class II DATEX--OHMEDA, INC.
May 19, 2023 Beside panel FRU (Field Replacement Units) Kits GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h... Class II DATEX--OHMEDA, INC.
May 19, 2023 Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-9... GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h... Class II DATEX--OHMEDA, INC.
May 18, 2023 Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYN... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... Class II Maquet Medical Systems USA
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases and damage to the acce... Class II Maquet Medical Systems USA
May 18, 2023 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Mo... 1. An accessory may be improperly placed during packaging, causing creases and damage to the acce... Class II Maquet Medical Systems USA
May 18, 2023 Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, n... Incorrect product code marked on the product, etched with product code MD611, however; the correc... Class II Aesculap Implant Systems LLC
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass M... Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... Class II Maquet Medical Systems USA
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 QUADROX-iR, used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... Class II Maquet Medical Systems USA
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield

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.