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Lower risk Medical device recall · FDA · Published January 3, 2020

Ethicon Coated VICRYL Suture Recall: Risk of Suture Fraying

Ethicon recalls Coated VICRYL (Polyglactin : 18" sutures with lot number PGZ908 may have frayed sections that could reduce tensile strength during surgery.

🇺🇸 FDA recall #Z-0989-2020Medical deviceEthicon ›
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Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
✎ GovInfoNow plain-language explainer

Ethicon is recalling 18-inch Coated VICRYL sutures with lot number PGZ908 because some may have frayed sections that could weaken the suture during use. This could lead to the suture breaking under tension, potentially causing complications during medical procedures. Read more at govinfonow.com/recall/66171-ethicon-coated-vicryl-suture-recall-risk-of-suture-fraying.

Source Summary by GovInfoNow · govinfonow.com/recall/66171-ethicon-coated-vicryl-suture-recall-risk-of-suture-fraying · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0989-2020

Cite this page

“Ethicon Coated VICRYL Suture Recall: Risk of Suture Fraying.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66171-ethicon-coated-vicryl-suture-recall-risk-of-suture-fraying. Based on FDA recall #Z-0989-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0989-2020%22&limit=1).

Ethicon, Inc. recalled Coated VICRYL (Polyglactin 910) Suture, 18" (45cm), Product Code J497H, on Jan. 3, 2020, according to the FDA. Some sutures in lot PGZ908 may exhibit braid fraying leading to reduced tensile strength.

How to tell if you have it

  • Brand: Ethicon
  • Product: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm)
  • Product Code: J497H
  • Lot Code: PGZ908
  • Units Affected: 23688

The hazard

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

Context

GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Other recent recalls of similar products include Ethicon Monocryl" Sutures Recall (2024-10-08), Ethicon Coated VICRYL Suture Recall (2024-09-25), and Ethicon PDS II Suture Recall (2024-05-10). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), da Vinci S Si Tenaculum Forceps (2025-12-09), and Genesis Push-In Suture Anchor Recall (2025-12-17).

How to tell if you have this one

Check for the product code J497H and lot number PGZ908 on the suture packaging. This recall applies to 18-inch (45cm) Coated VICRYL sutures sold by Ethicon.

  • Brand
    Ethicon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Suture Packaging

    Look for the product code J497H and lot number PGZ908 on the suture packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Domestic distribution nationwide. US and Puerto Rico only.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Jan 3, 202012. FDA classified it Class II: Feb 4, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Aug 13, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this suture safe to use?

The recall indicates that some sutures in this lot may have frayed sections that could reduce tensile strength, so it is not recommended for use without checking the recall status.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0989-2020 (January 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0989-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA