Recall archive
36 recalls · page 2 of 2
Reported Mar 28, 2018
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Reason for recall — Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Reason for recall — On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin…
FDA (openFDA device enforcement)
Reported Oct 5, 2016
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details · Reason for recall — ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a…
FDA (openFDA device enforcement)
Reported Jun 22, 2016
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Reason for recall — Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels…
FDA (openFDA device enforcement)
Reported Jan 13, 2016
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details — Stability data does not substantiate the labeled two-year shelf life of affected product.
FDA (openFDA device enforcement)
Reported Jul 1, 2015
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
FDA (openFDA device enforcement)
Reported Dec 10, 2014
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
FDA (openFDA device enforcement)
Reported Apr 9, 2014
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details — The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
FDA (openFDA device enforcement)
Reported Dec 18, 2013
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal…
FDA (openFDA device enforcement)
Reported Nov 28, 2012
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ethicon, Inc.
Matched: Brand · Product · Product details — SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2012
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product details · Reason for recall — Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a…
FDA (openFDA device enforcement)
Reported Jul 4, 2012
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details — The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air…
FDA (openFDA device enforcement)
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