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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

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Aug 13, 2018 CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: Y... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 1, 2018 Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Jul 10, 2018 HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... Class II Arrow International Inc
Jul 10, 2018 HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... Class II Arrow International Inc
Jun 27, 2018 Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T... Incomplete seal on the Tyvek lid may compromise the sterility of the device Class II Stryker GmbH
May 10, 2018 medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 0... Product has a lack of sterility assurance Class II Smiths Medical ASD Inc.
May 7, 2018 PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PRONOVA SUTURE BLUE 122CM M1.5, D10189 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 11, 2018 Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product C... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Code: ASK-01000-UPMS Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue Fl... Product sterility may be compromised due to unsealed packaging. Class II Arrow International 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.