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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

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Jul 6, 2020 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Dro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Ye... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Produ... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usa... Insufficient amount of antibody without an error message or alarm Class II Sysmex America, Inc.
Jul 6, 2020 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotatin... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 p... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Re... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Val... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Ro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cl... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 Micro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave R... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/R... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn,... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave C... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 S... Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have ... Class II OrthoPediatrics Corp
Jul 6, 2020 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Base... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class II Gentueri Inc
Jul 6, 2020 Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 un... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 u... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 5, 2020 DYNEX Agility, Agility Analyzer, Model No. 67000 Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.... Class II Dynex Technologies, Inc.
Jul 2, 2020 PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1 The rivets that secure the elastic headband to the face shield have the potential to be mis-assem... Class II Whirlpool Corporation
Jul 1, 2020 REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClav... Incorrect filter assemblies in IV administration set. Class II ICU Medical, Inc.
Jun 30, 2020 Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained ... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 IntelliVue MX700 patient monitor, model no. 865241 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... Class II Philips North America, LLC
Jun 30, 2020 Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage:... Potential for sterile packaging to be compromised¿ Class II TELEFLEX MEDICAL INC
Jun 30, 2020 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... There are reports of the suction catheter coming apart from the device assembly during use. Class II Medline Industries Inc
Jun 30, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
Jun 30, 2020 Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used ... Affected beds may have screws installed that do not meet material tensile strength requirements. ... Class II Hill-Rom, Inc.
Jun 30, 2020 Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide traine... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8000 modular infusion pump and monitoring system If one or more screws or washers are loose or missing causing the battery not to be properly secu... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 IntelliVue MX800 patient monitor, model no. 865240 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... Class II Philips North America, LLC

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.