Ethicon recalls
Ethicon appears in 76 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare… - Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45
FDA Device · Class II · 2018-05-02 · Ethicon
Reason: Products labeled for distribution outside the United States may have been distributed to customers in the United States. - PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
FDA Device · Class II · 2018-04-18 · Ethicon
Reason: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from… - PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
FDA Device · Class II · 2018-04-18 · Ethicon
Reason: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from… - PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
FDA Device · Class II · 2018-04-18 · Ethicon
Reason: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from… - DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easil…
FDA Device · Class II · 2018-03-28 · Ethicon
Reason: Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off. - Coated VICRYL RAPIDETM (Polyglactin 910) Suture
FDA Device · Class II · 2018-03-07 · Ethicon
Reason: On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods te… - ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
FDA Device · Class II · 2016-10-05 · Ethicon
Reason: ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorre… - EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel
FDA Device · Class II · 2016-06-22 · Ethicon
Reason: Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-1… - Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc
FDA Device · Class II · 2016-01-13 · Ethicon
Reason: Stability data does not substantiate the labeled two-year shelf life of affected product. - Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutt…
FDA Device · Class II · 2015-07-01 · Ethicon
Reason: Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. - Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA
FDA Device · Class II · 2014-12-10 · Ethicon
Reason: Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. - Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias…
FDA Device · Class II · 2014-04-09 · Ethicon
Reason: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. - Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969
FDA Device · Class II · 2013-12-18 · Ethicon
Reason: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. - ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc
FDA Device · Class I · 2012-11-28 · Ethicon
Reason: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. - ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc
FDA Device · Class I · 2012-11-28 · Ethicon
Reason: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. - EVICEL Fibrin Sealant (Human) Rx Only
FDA Device · Class II · 2012-10-31 · Ethicon
Reason: Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be rela… - Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactur…
FDA Device · Class II · 2012-07-04 · Ethicon
Reason: The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.