Z-2920-2026Class II
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Medtronic, Inc. / initiated 2026-06-24 / Open, Classified / root cause: manufacturing process
Covidien, LP began a recall of Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2920-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
- Product code
- GAR Suture, Nonabsorbable, Synthetic, Polyamide
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- 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.
- Quantity in commerce
- 135,875 total
- 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.
- Product codes and lots
- 88861757-31 UDI-DI 10884521070912 Lot D6A3020FY UDI-DI 20884521070919 Lot D6A3020FY 88861799-31 UDI-DI 20884521071060 Lot D6A2861FY
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2918-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2919-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2920-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2921-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2922-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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