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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 31, 2020 Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 24, 2020 Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... Class II Irvine Biomedical Inc, a St. Jude Medical Co.
Aug 24, 2020 Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... Class II Irvine Biomedical Inc, a St. Jude Medical Co.
Aug 18, 2020 Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 13, 2020 Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr... Masks processed at one site were not maintained at levels of condensation during a portion of the... Class II Battelle Memorial Institute
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm,... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Stryker IsoAir 2.0 support surface-provides pressure redistribution and is in... Connector between support surface and pump may be out of tolerance resulting in difficulty in rem... Class II Stryker Medical Division of Stryker Corporation
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Jul 27, 2020 JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces Test results revealed that the KN95 masks failed to filter greater than 95% of particulates. Class II Office Depot Inc
Jul 24, 2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... Class II Intrinsic Therapeutics, Inc.
Jul 21, 2020 DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm -... May have one or more dimensional features out of tolerance includes: thread pitch diameter depth,... Class II Synthes (USA) Products LLC
Jul 14, 2020 Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
Jul 14, 2020 Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
Jul 6, 2020 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4... 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 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit ... 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 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifol... 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 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, Na... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)108406... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave M... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UD... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, Micro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clam... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Co... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per po... 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 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, Nano... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, N... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, 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.