Covidien, Lp: Suture, Nonabsorbable, Synthetic, Polyamide
Covidien is recalling Dermalon 4-0 BLU sterile sutures (specific lot numbers 88861757-31 and 88861799-31) because the sterile packaging may have perforations or tears that could allow contamination. The contaminated sutures could cause infection, vision loss if used in eye surgery, or require surgery to be extended. The affected products were distributed nationwide in the US and in numerous countries worldwide.
- Recalling firm
- Covidien, LP
- Product
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/59550d9a-966c-4552-a100-ec6047acd64e