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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 22, 2023 DiagnosUS Pregnancy Test Midstream REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 19, 2023 TruSignal Ear Sensor, REF TS-E-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
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 19, 2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Wrap Sensor, REF TS-W-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
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 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
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 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 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 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 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
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 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 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 ARROW Endurance Extended Dwell Peripheral Catheter System Potential for catheter separation or leakage Class I ARROW INTERNATIONAL Inc.
May 19, 2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
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 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class II Zimmer, Inc.
May 18, 2023 MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST... Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... 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 HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypas... 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 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 BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary by... 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 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
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 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 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 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 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 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

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.