FDA Device recall Z-1177-2023
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA by Covidien, citing sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1177-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-02 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Reason
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Identifiers
| code_info | GTIN: 20884521064710, 10884521064713 Model # Lot # D-1764K D1L2420Y D1L2428Y D1M2883Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1177-2023%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.