Lower riskMedical device recall · FDA · Published June 24, 2026
Covidien Dermalon 4-0 Blue 75cm Sutures Recall: Risk of Infection from Packaging Tears
Covidien recalls Dermalon 4-0 Blue 75cm sutures with possible packaging tears that could cause infection. Affected items have specific lot numbers and model codes. Consumers should check their product details.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
✎ GovInfoNow plain-language explainer
Covidien is recalling certain Dermalon 4-0 Blue 75cm sutures due to potential tears in the sterile packaging. This could lead to infection or vision loss if used in eye procedures. The recall affects specific model numbers and lot dates. Read more at govinfonow.com/recall/459480-covidien-dermalon-4-0-blue-75cm-sutures-recall-risk-of.
“Covidien Dermalon 4-0 Blue 75cm Sutures Recall: Risk of Infection from Packaging Tears.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459480-covidien-dermalon-4-0-blue-75cm-sutures-recall-risk-of. Based on FDA recall #Z-2920-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2920-2026%22&limit=1).
The FDA announced on June 24, 2026, that Covidien, LP is recalling Dermalon sterile sutures due to potential perforations in the packaging. This defect may lead to biocontamination and subsequent infection or loss of vision. The recall affects 135,875 units distributed nationwide and internationally.
The product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Context
GovInfoNow's records show Covidien, LP has 26 other recalls on record since 2017-07-17. Other recent recalls include the 2026-04-15 Covidien EndoStitch Polysorb Loading Unit Recall and the 2025-09-25 Covidien Signia Small Diameter Curved Tip Recall. Similar recent recalls of sterile medical products include the 2026-06-12 Medline Eye Kits Recall, the 2026-06-12 Medline Convenience Kits Recall regarding sterile packaging breach, and the 2026-06-12 Medline Convenience Kits Recall concerning microbial contamination.
How to tell if you have this one
Check for model numbers 88861757-31 (C13) or 88861799-31 (C14) with lot numbers D6A3020FY or D6A2861FY. These sutures were sold with specific UDI-DI codes.
Brand
Covidien
Category
Medical device
FDA recall event · 5 products
All 5 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
US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX; S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model numbers 88861757-31 (C13) or 88861799-31 (C14) and lot numbers D6A3020FY or D6A2861FY on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-2920-2026 (June 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2920-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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.