FDA Device recall Z-2922-2026
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX 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-2922-2026 |
| 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 II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
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 | S8698GX UDI-DI 20612479214716 Lot D5M3438FY |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2922-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.