Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31

FDA Recall Z-2920-2026 · Posted 2026-08-07

Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeGAR
Date Initiated2026-06-24
Product Quantity135,875 total

Reason for Recall

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.

Firm Action

The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, "URGENT: VOLUNTARY MEDICAL DEVICE RECALL." Customers were informed of the manufacturing nonconformance. If products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination. Customers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic. The recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981582SURGILON, DERMALON, & OPHTHALONDavis & Geck, Inc. · 1998-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑