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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

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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

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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.

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DateProductReasonClassFirm
May 1, 2023 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
May 1, 2023 BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use ... IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and th... Class II Becton Dickinson & Co.
Apr 28, 2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PC... Faulty cartridges in the lot could result in false test results. Class II Qiagen Sciences LLC
Apr 28, 2023 Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for us... Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for... Class II TELEFLEX LLC
Apr 27, 2023 Intelli-C, Right side suspended Tabletop, REF: 03400000 There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... Class II NRT X-RAY A/S
Apr 27, 2023 Intelli-C, Left side suspended Tabletop, REF: 03400010 There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... Class II NRT X-RAY A/S
Apr 26, 2023 HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel... Class II HeartSine Technologies Ltd
Apr 26, 2023 MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... The wrong tibia guide was included intended for a different patient case. Class II Materialise N.V.
Apr 25, 2023 Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... Class II Philips North America
Apr 25, 2023 Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... Class II Philips North America
Apr 25, 2023 Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... Class II Davol, Inc.
Apr 25, 2023 Incisive CT-Computed Tomography X-Ray System Model: 728143 Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... Class II Philips North America
Apr 25, 2023 Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated... Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... Class II Davol, Inc.
Apr 25, 2023 Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... Class II Philips North America
Apr 25, 2023 Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, ... Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... Class II Davol, Inc.
Apr 25, 2023 SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c... Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to b... Class II LumiraDx
Apr 25, 2023 FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011... The firm has identified an increased risk of obtaining false positive Cryptosporidium results fro... Class II BioFire Diagnostics, LLC
Apr 25, 2023 Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, ... Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... Class II Davol, Inc.
Apr 25, 2023 LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, S... Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite ... Class II Linkbio Corp.
Apr 24, 2023 AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... Class II Cepheid
Apr 24, 2023 Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover ... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Apr 24, 2023 Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Co... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Apr 24, 2023 Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... Class II Cepheid
Apr 24, 2023 SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
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 24, 2023 Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Li... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Apr 24, 2023 SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower ... Class III Abbott Ireland Limited
Apr 24, 2023 AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, 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 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 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 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 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 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 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 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 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 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, 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 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 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 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 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 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: 2503 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 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, 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

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.