Recall Z-2921-2026— Covidien, LP
Class II · Ongoing
Class II FDA medical device recall by Covidien, LP, initiated 2026-06-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623. 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..
- Recalling firm
- Covidien, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-24
- Firm location
- North Haven, CT, United States
Product description
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.