FDA Device recall Z-1178-2023
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31…
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31… 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-1178-2023 |
| 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
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12
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: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 2…GTIN: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 20884521071794, 20884521071763, 20884521071787, 20884521071749, 10884521073838, 20884521073835, 20884521076669, 10884521076662, 10884521071766, 20884521071725, 10884521071513, 20884521071510. Model Number Lot # 8886188351 D1K1677FY 8886191571 D2C3242Y 8886191931 D2B2243Y 8886191941 D1M2553Y D1M2561Y D2B0169Y 8886191951 D1M0915Y D2A0560Y D2B1245Y D2B1537Y D2B2751Y D2C0267Y D2C0907Y D2C1101Y D2D2347Y D2D2437Y D2D2506Y D2D2510Y D2E0905Y 8886191961 D1M1423Y D2A0861Y D2A0865Y D2A1709Y D2B1349Y D2B1350Y D2B2727Y 8886191971 D1M0640Y D1M1494Y D2C0962Y 8886193251 D1G1867Y 8886197171 D2B0290Y D2B0445Y D2B0476Y 8886198571 D1E0626Y SBS1884G D1E1212FY SBS1928G D2B0707FY D2C3247FY |
|---|
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-1178-2023%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.