Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 48

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.

The notice also names 40 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Ethicon, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Ethicon, LLC

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Same hazard · sterility breach