Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

Clear
DateProductReasonClassFirm
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
Apr 11, 2018 Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue F... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Produ... 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 with Blue ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N... 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 with Blue ... 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 with Blue ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-2430... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Echogenic Needle; Product codes: PN-00215-E and PN-00217-E Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Multi-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 Maximal Barrier Drape; Product Codes: ASK-00376-SU 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

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.