Ethicon PROLENE Suture Recall: Risk of Infection from Open Packaging
Ethicon recalls specific PROLENE Polypropylene Suture models due to potential open packaging that could breach sterility and cause infections. Affected items include REF: EH7585H, 8706H, 8833H, 8963H, 8935H with expiration dates through August 2029.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Ethicon is recalling specific PROLENE Polypropylene Suture models because some packages may have an open seal, which could lead to contamination and infection during medical procedures. This is a serious risk for patients undergoing surgery. Read more at govinfonow.com/recall/53180-ethicon-prolene-suture-recall-risk-of-infection-from-open-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/53180-ethicon-prolene-suture-recall-risk-of-infection-from-open-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1096-2025
Cite this page
“Ethicon PROLENE Suture Recall: Risk of Infection from Open Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53180-ethicon-prolene-suture-recall-risk-of-infection-from-open-packaging. Based on FDA recall #Z-1096-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2025%22&limit=1).
Why it’s dangerous
The sutures may have an open seal on the primary packaging due to a manufacturing issue. If undetected, this could breach sterility, introducing pathogens to the patient and causing infections during medical procedures.
Who’s affected
Medical professionals using these sutures for surgeries, particularly in cardiovascular, ophthalmic, or neurosurgical procedures. Patients undergoing surgery with these sutures are at risk of infection.
How to tell if you have this one
Check the product reference codes: EH7585H, 8706H, 8833H, 8963H, or 8935H. These sutures were sold with expiration dates through August 2029.
- Brand
Ethicon- Category
Medical device
All 3 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
Ongoing- Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1096-2025 | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.; REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029) | 15,948 |
| Z-1097-2025 | PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.; REF/UDI-DI-GTIN/Lot(expiration): F2416H/10705031238947/103E7C(8/31/2029); EH7808B/10705031239425/103E7A(8/31/2029); 661H/10705031007703/103GR7(8/31/2029), 103H5A(8/31/2029); 1669H/10705031001879/103GR2(8/31/2029), 103J14(8/31/2029); 644H/10705031089594/103EXA(8/31/2029); EH7827B/10705031239074/103EX9(8/31/2029); F3223BH/10705031240940/103EJH(8/31/2029); EH7797BH/10705031239487/103J2H(8/31/2029); 628H/10705031007000/1033PK(7/31/2029); 699G/10705031008625/102TMJ(7/31/2029); K872H/10705031044586/103DBT(8/31/2029); W723H/10705031202450/103G13(8/31/2029); 623H/10705031006898/10386S(8/31/2029); K833H/10705031044388/103K99(8/31/2029); 6664H/10705031089808/103G1B(8/31/2029); X425H/10705031057296/103H4B(8/31/2029); X872H/10705031058187/103DBT(8/31/2029); EH7491H/10705031096806/103D42(8/31/2029) | 78792 |
| Z-1098-2025 | ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US; REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029) | 48 |
What to do — step by step
Check Product Labels
Look for reference codes EH7585H, 8706H, 8833H, 8963H, or 8935H on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 40 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1096-2025 (December 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1096-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.