The Recall Desk

Manufacturer

Ethicon, Inc.

70 recalls in our database name Ethicon, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
70
Critical
0
Severe
3
Most recent
2024-11-27

Of the 70 recalls from Ethicon, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–70 of 70

  • HighFDA (Devices)·Z-2460-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline sutures because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2459-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling specific Prolene suture products because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2458-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline sutures because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-1534-2018·2018-05-02

    Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error

    Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.

    Product
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1339-2018·2018-04-18

    Ethicon Recalls PDS Plus Sutures Due to Incorrect Expiry Date Labeling

    Ethicon, Inc. is recalling PDS Plus Antibacterial Sutures because three lots were labeled with a five-year expiry date instead of the correct two-year date.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2018·2018-04-18

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates

    Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they were labeled with an incorrect expiry date of five years instead of two.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1340-2018·2018-04-18

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates

    Ethicon is recalling PDS Plus Antibacterial Sutures because three lots were labeled with an incorrect five-year expiry date instead of the correct two-year date.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2018·2018-03-28

    Ethicon Recalls DERMABOND PRINEO Skin Closure System Lots

    Ethicon is recalling specific lots of the DERMABOND PRINEO Skin Closure System because the adhesive may not dry within the specified time and may fall off.

    Product
    DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2018·2018-03-07

    Ethicon Recalls VICRYL RAPIDE Suture Lots Due to Tensile Failure

    Ethicon is recalling 25 lots of VICRYL RAPIDE suture because the material failed knot tensile strength testing during quality control.

    Product
    Coated VICRYL RAPIDETM (Polyglactin 910) Suture
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2889-2016·2016-10-05

    Ethicon Mersilene Tape Recalled for Incorrect Instructions for Use Insert

    Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.

    Product
    ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2016·2016-06-22

    Ethicon Recalls EVARREST Fibrin Sealant Patch Due to Labeling Error

    Ethicon is recalling 228 units of EVARREST Fibrin Sealant Patch because the expiration date field on the foil pouch labels contains the text '0-bad' instead of the valid date.

    Product
    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2016·2016-01-13

    Ethicon Recalls Gynecare Thermachoice III Uterine Balloon Therapy System

    Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System because stability data does not support the labeled two-year shelf life.

    Product
    Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (exc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1839-2015·2015-07-01

    Ethicon Recalls Surgical Sutures Due to Incomplete Labeling

    Ethicon is recalling specific lots of Fast Absorbing Plain Gut sutures because the box and foil labels are incomplete.

    Product
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2015·2014-12-10

    Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns

    Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.

    Product
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2014·2014-04-09

    Ethicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise

    Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.

    Product
    Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0458-2014·2013-12-18

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled

    Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.

    Product
    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2013·2012-11-28

    Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect

    Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applyi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0292-2013·2012-11-28

    Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2013·2012-10-31

    Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports

    Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.

    Product
    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2012·2012-07-04

    Ethicon Surgiflo Hemostatic Matrix Kit Recalled for Potential Non-Sterility

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits with Thrombin because an undetected air leak during manufacturing may have compromised the sterility of the thrombin component.

    Product
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thromb
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ethicon Inc.

pharmaceutical company

Country
United States
Founded
1930
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q3733763), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.