Ethicon recalls ETHIBOND EXCEL suture due to potential high endotoxin levels
Ethicon recalls ETHIBOND EXCEL polyester suture (Product Code X42: PBQ426) because it may contain high endotoxin levels. This could pose a risk during medical procedures.
Lower-risk recall
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Contact the company
What happened, in plain English
Ethicon is recalling ETHIBOND EXCEL polyester suture (Product Code X425H, Lot PBQ426) because it may have been made with high endotoxin levels. This could cause a reaction during surgery or medical procedures. Read more at govinfonow.com/recall/68114-ethicon-recalls-ethibond-excel-suture-due-to-potential-high-endotoxin.
Source Summary by GovInfoNow · govinfonow.com/recall/68114-ethicon-recalls-ethibond-excel-suture-due-to-potential-high-endotoxin · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1841-2019
Cite this page
“Ethicon recalls ETHIBOND EXCEL suture due to potential high endotoxin levels.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68114-ethicon-recalls-ethibond-excel-suture-due-to-potential-high-endotoxin. Based on FDA recall #Z-1841-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1841-2019%22&limit=1).
Why it’s dangerous
Endotoxins are natural components of bacteria that can cause infections or reactions when introduced into the body. High levels in the suture could lead to adverse reactions during surgery.
Who’s affected
Medical professionals who use this suture for procedures like cardiovascular, ophthalmic, or neurological surgeries. Patients undergoing these procedures are at risk if the suture is used.
How to tell if you have this one
Check for the product name 'ETHIBOND EXCEL Polyester Suture', model 'Green 75cm USP1 Single Armed CT-1', and product code 'X425H' with lot code 'PBQ426'.
- Brand
Ethicon- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1841-2019 | ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures; Lot Code: PBQ426 | 1296 eaches |
| Z-1842-2019 | ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures; Lot Code:PBQ797 | 36 eaches |
What to do — step by step
Check Product Details
Verify the product code (X425H) and lot code (PBQ426) on the suture packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
FDA distribution: “Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Iowa, New Jersey, Rhode Island, Texas, West Virginia.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1841-2019 (April 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1841-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.