# FDA recall Z-1180-2023

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

## Product

Surgipro II Monofilament Polypropylene Sutures  Product Description	Model Number  VP-421X SURGIPRO*II 4-0 90CM V20 DA7P	VP421X  VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P	VP435X  VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA	VP541X  VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA	VP542X  VP-735-X SURGIPRO*II 7-0 60CM MV1758DA	VP735X  VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA	VP735X12  VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA	VP738X  VP-744-X SURGIPRO*II 8-0 45CM MV1758DA	VP744X  VP-745-X SURGIPRO*II 8-0 60CM MV1758DA	VP745X  VP-747-X SURGIPRO*II 7-0 75CM MV1758DA	VP747X  VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA	VP853  VP-875-X SURGIPRO*II 7-0 75CM MV1759DA	VP875X  VP-900-X SURGIPRO*II 8-0 45CM MV1355DA	VP900X  VP-902-X SURGIPRO*II 8-0 60CM MV1355DA	VP902X  VP-421X SURGIPRO*II 4-0 90CM V20 DA7P	VP421X  VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P	VP435X  VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA	VP541X  VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA	VP542X  VP-735-X SURGIPRO*II 7-0 60CM MV1758DA	VP735X  VP735X-12 SURGIPR

## 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-1180-2023
- **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-1180-2023

## Citation

> AI Analytics. FDA recall Z-1180-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1180-2023. Source: US FDA. Licensed CC0.

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