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Browse Device Recalls

70 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 70 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 70 FDA device recalls.

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DateProductReasonClassFirm
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.
Mar 7, 2018 Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. ... Products labeled for distribution outside the United States may have been distributed to customer... Class II Ethicon, Inc.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Nov 27, 2017 DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO ... Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified... Class II Ethicon, Inc.
Aug 17, 2017 Coated VICRYL RAPIDETM (Polyglactin 910) Suture On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twe... Class II Ethicon, Inc.
Aug 1, 2016 ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Str... ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fib... Class II Ethicon, Inc.
Apr 11, 2016 EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd... Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in... Class II Ethicon, Inc.
Dec 3, 2015 Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The... Stability data does not substantiate the labeled two-year shelf life of affected product. Class II Ethicon, Inc.
May 8, 2015 Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Sur... Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the ... Class II Ethicon, Inc.
Oct 17, 2014 Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethic... Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expec... Class II Ethicon, Inc.
Feb 19, 2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... Class II Ethicon, Inc.
Sep 25, 2013 Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon L... Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab fai... Class II Ethicon, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Jul 2, 2012 EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceu... Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in ass... Class II Ethicon, Inc.
Apr 3, 2012 Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distribut... The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the po... Class II Ethicon, 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.