The Recall Desk
HighFDA (Devices)·Z-1098-2025·Announced 2025-02-12

Surgical sutures recalled for potential sterility breach

Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device where a manufacturing defect (open seal) creates risk of sterility breach and potential serious patient harm through infection. Per the rubric, risk-of-harm products where injury has not yet been reported qualify for Score 3. No illnesses have been reported, and the hazard remains theoretical, which caps the score at 3.

Plain-English summary

Ethicon, LLC is recalling specific lots of ETHIBOND EXCEL Polyester Suture (REF codes 6664H, X425H, X872H, EH7491H) due to open seals on the primary packaging discovered during manufacturing quality review.

The open seal results from a manufacturing defect on a specific production machine. If undetected, this defect could breach the product's sterility and allow pathogens to contaminate the sutures. Because these sutures are implanted directly into surgical wounds, any contamination could introduce infection to patients.

The affected sutures were distributed worldwide, including throughout the United States. The recalled lot is W8003T with expiration date 8/31/2029. As of this notice, no illnesses or infections have been reported.

If you have this product or administered it to patients, contact Ethicon, LLC immediately for further instructions. Do not use affected sutures if you suspect the package seal has been compromised or opened.

The recalled product

Product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Manufacturer
Ethicon, LLC
Category
Medical Device — Surgical Sutures
Hazard
  • sterility-breach
  • infection-risk
  • packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)

Distribution

Distributed nationwide across the United States.

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