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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
Apr 24, 2023 ambIT Cassette Filter Male Luer, Product Code: 220266 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx On... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx On... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 21, 2023 Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (... The kits were damaged by water. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 20, 2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 19, 2023 Patient Information Center iX, Product Code 866386, and Patient Information C... During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... Class II Philips North America
Apr 18, 2023 Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA II... The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the end... Class II Olympus Corporation of the Americas
Apr 17, 2023 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTIO... The custom procedure packs contain light handle covers that have been recalled by another firm. Class II DeRoyal Industries Inc
Apr 17, 2023 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Class II Ortho-Clinical Diagnostics, Inc.
Apr 17, 2023 Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK,... The custom procedure packs contain light handle covers that have been recalled by another firm. Class II DeRoyal Industries Inc
Apr 14, 2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 ... Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in ... Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2023 REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only N... Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Com... Class II Stryker Sustainability Solutions
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 12, 2023 Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... The product contains an expired diluent vial. If the impacted product is used, the sterility of t... Class II TELEFLEX LLC
Apr 12, 2023 Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Ultraview SL (UVSL) Command Module, Model 91496 Command modules will display the following when parameter processing is suspended, depending on s... Class II Spacelabs Healthcare, Inc.
Apr 12, 2023 Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 11, 2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placem... Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Dril... Class II Integra LifeSciences Corp.
Apr 11, 2023 Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM;... Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter a... Class II Bard Peripheral Vascular Inc
Apr 10, 2023 Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Apr 10, 2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present in the drying chambe... Class II Steris Corporation
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Apr 10, 2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reli... Class II Keystone Industries

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.