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Browse Device Recalls

140 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 140 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 140 FDA device recalls.

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DateProductReasonClassFirm
Feb 13, 2020 DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral ... Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... Class II Merit Medical Systems, Inc.
Feb 13, 2020 DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Verte... Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... Class II Merit Medical Systems, Inc.
Sep 12, 2019 Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is t... labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the in... Class II Merit Medical Systems, Inc.
Oct 26, 2018 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX ... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Oct 26, 2018 Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, R... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Jul 9, 2018 ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... A nonsterile bulk product designated for further processing in a tray was inadvertently shipped t... Class II Merit Medical Systems, Inc.
Feb 2, 2018 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids... Supplier manufacturing defect with the syringe plunger tip. Class II Merit Medical Systems, Inc.
Dec 20, 2017 Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: ... Mix-up between adult and pediatrics PD catheter. Class II Merit Medical Systems, Inc.
Dec 14, 2017 PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, C... Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP ... Class II Merit Medical Systems, Inc.
Sep 20, 2017 Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Pe... 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these ... Class II Merit Medical Systems, Inc.
Sep 20, 2017 Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog ... 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. Class II Merit Medical Systems, Inc.
Sep 20, 2017 Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Pe... 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these ... Class II Merit Medical Systems, Inc.
Mar 23, 2017 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K... Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a... Class II Merit Medical Systems, Inc.
Mar 3, 2017 The PreludeSYNC Radial Compression Device is a sterile, single use disposable... Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compres... Class II Merit Medical Systems, Inc.
Feb 16, 2017 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, P... Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F P... Class I Merit Medical Systems, Inc.
Dec 1, 2016 PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydr... Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dil... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Fluid Management Set. Catalog Number K08-MP5159A Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Waste Management Kit. Catalog Number K10-04381AP Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Manifold Kit. Catalog Number K09-11867AP Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Sep 23, 2016 Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedur... Class II Merit Medical Systems, Inc.
Aug 25, 2016 Merit Inflation Syringe Kit. Catalog Number KOS-02857 Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due... Class II Merit Medical Systems, Inc.
Aug 12, 2016 Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contras... Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due ... Class II Merit Medical Systems, Inc.
Mar 15, 2016 Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to c... Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal... Class II Merit Medical Systems, Inc.
Jun 29, 2015 ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are inten... Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy bet... Class II Merit Medical Systems, Inc.
Jun 4, 2015 Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-... Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled... Class II Merit Medical Systems, Inc.
Sep 26, 2014 Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, No... These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. Class II Merit Medical Systems, Inc.
Apr 14, 2014 Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Ti... Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm... Class II Merit Medical Systems, Inc.
Apr 14, 2014 Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard S... Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the c... Class II Merit Medical Systems, Inc.
Mar 13, 2014 Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) ... The products are labeled as sterile but were not sterilized. Class II Merit Medical Systems, Inc.
Mar 13, 2014 Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A... The products are labeled as sterile but were not sterilized. Class II Merit Medical Systems, Inc.
Dec 18, 2013 Radial Assist RAD BOARD, used to support the weight of a patient's arm and s... Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 device... Class II Merit Medical Systems, Inc.
Dec 6, 2013 Catheter, Continuous Flush The Merit Microcatheter is intended for general i... Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a gr... Class II Merit Medical Systems, Inc.
Sep 30, 2013 Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I... Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c... Class I Merit Medical Systems, Inc.
Sep 13, 2013 Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560... 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. Class II Merit Medical Systems, Inc.
May 2, 2013 Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: ... Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0... Class II Merit Medical Systems, Inc.
Jan 16, 2013 Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Model... A consumer complaint that a catheter was observed to be in several pieces under patient fluorosco... Class II Merit Medical Systems, Inc.
Nov 21, 2012 Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tra... Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the se... Class II Merit Medical Systems, Inc.
Sep 14, 2012 Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02... Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because o... Class II Merit Medical Systems, Inc.
Jun 8, 2012 Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's T... Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear t... Class II Merit Medical Systems, 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.