# FDA recall Z-1176-2023

> **Covidien, LP** · Class II · device recall initiated 2022-12-02.

## Product

Sofsilk Coated Braided Silk Suture Product Description									  CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36	CS211  CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36	CS490  CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36	CS562  GS-823 SOFSILK* 2-0 BLK 75CM V30 X36	GS823  GS-835 SOFSILK* 1 BLK 75CM V20 X36	GS835  S-1172 SOFSILK* 6-0 BLK 45CM C1 X36	S1172  S-1173 SOFSILK* 5-0 BLK 45CM C1 X36	S1173  S-1174 SOFSILK* 4-0 BLK 45CM C1 X36	S1174  S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12	S1750K  S-176 SOFSILK* 0 BLK 12X45CM PCT X24	S176  S-176 SOFSILK* 0 BLK 12X45CM PCT X24	S176  S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12	S1768K  S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36	S182  S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36	S183  S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36	S184  S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36	S185  S-187 SOFSILK* 1 BLK 6X45CM PCT X36	S187  S-206 SOFSILK* 2 BLK 100CM STDLTH X36	S206  S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36	S243  S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36	S244  S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36	S245  S

## Reason for recall

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

## Distribution

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

## Key facts

- **Recall number:** Z-1176-2023
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-02
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2023

## Citation

> AI Analytics. FDA recall Z-1176-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1176-2023. Source: US FDA. Licensed CC0.

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