FDA Device recall Z-2921-2026
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 by Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2921-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-24 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Covidien |
| Distribution | US |
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.
Identifiers
| code_info | SP-623 UDI-DI 20884521037073 Lot D6A2963Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2921-2026%22
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