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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Jul 20, 2018 CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection devic... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device use... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device use... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connectio... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connecti... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection ... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection ... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection d... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection devic... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connectio... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trillia... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model ... A small number of devices in this lot may have a melted cap and a hole formed through the packagi... Class II Beaver Visitec
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 18, 2018 The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon ... Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dil... Class II Shockwave Medical, Inc.
Jul 18, 2018 Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Ca... The device was built with the rigid insertion stylet instead of the flexible stylet. Class II Surge Medical Sales, LLC (DBA Surge Cardiovascu...
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. The product has a stability issue which may lead to an error code indicating "Unable to calculate... Class II Abbott Laboratories, Inc
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. The product has a stability issue which may lead to an error code indicating "Unable to calculate... Class II Abbott Laboratories, Inc
Jul 18, 2018 Sedecal NOVA FA DR System. for diagnostic radiography. A safety problem with installation and maintenance could lead to the breakage of the two steel ca... Class II Sedecal S.A.
Jul 18, 2018 P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 This unit may be missing the screw/collet Assembly Class II DePuy Orthopaedics, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... Class II Arrow International Inc
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, 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.