RegWardenFDA facility compliance records
Facility

ETHICON SARL

36 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 3 recalls; 2013: 1 recalls; 2014: 2 recalls; 2015: 2 recalls; 2016: 2 recalls; 2017: 2 recalls; 2018: 5 recalls; 2019: 4 recalls; 2020: 4 recalls; 2021: 1 recalls; 2022: 4 recalls; 2023: 1 recalls; 2024: 5 recalls3’121’132’142’152’162’175’184’194’201’214’221’235’24’25’26
  • Recalls (36)

Devices registered here (1)

  • Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
    Product code OTN (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300

Recalls & enforcement

20245 records
  • Class IIOngoing2024-12-20
    Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
  • Class IIOngoing2024-09-25
    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
  • Class IIOngoing2024-05-10
    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
  • Class IIOngoing2024-04-23
    Some applicator tips from these lots had open seals.
  • Class IIOngoing2024-03-08
    Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
20231 record
  • Class IIOngoing2023-03-31
    Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
20224 records
  • Class IIOngoing2022-11-16
    knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
  • Class IIOngoing2022-09-20
    Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
  • Class IIOngoing2022-08-08
    Product may contain the incorrect material which could impact treatment.
  • Class IIOngoing2022-03-24
    Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
20211 record
  • Class IITerminated2021-01-04
    Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
20204 records
  • Class IITerminated2020-10-23
    The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
  • Class IITerminated2020-09-09
    Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in le…
  • Class IIOngoing2020-06-10
    Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
  • Class IITerminated2020-01-03
    Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
20194 records
20185 records
  • Class IITerminated2018-12-18
    The sutures inside the packaging are not the same size or type as indicated on the label.
  • Class IITerminated2018-06-08
    Products do not meet a tensile strength specification
  • Class IITerminated2018-05-07
    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 professional handling the subject product or a patient infec…
  • Class IITerminated2018-03-07
    Products labeled for distribution outside the United States may have been distributed to customers in the United States.
  • Class IITerminated2018-01-10
    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 date of manufacture.
20172 records
  • Class IITerminated2017-11-27
    Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
  • Class IITerminated2017-08-17
    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 testing, a suture damage was identified on a lot of VICRYL R…
20162 records
  • Class IITerminated2016-08-01
    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 incorrect Instructions for Use (IFU) insert.
  • Class IITerminated2016-04-11
    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 (2016-12-28).
20152 records
20142 records
  • Class IITerminated2014-10-17
    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
  • Class IIOngoing2014-02-19
    The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
20131 record
  • Class IITerminated2013-09-25
    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
20123 records
  • Class ITerminated2012-08-21
    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.
  • Class IITerminated2012-07-02
    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 related to the use of the spray device at higher-than-recommended…
  • Class IITerminated2012-04-03
    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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ETHICON SARL (FEI 3003702646) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003702646-ethicon-sarl/

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