# FDA recall Z-1182-2023

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

## Product

Custom Suture Pack  Product Description:  US1638 CUSTOM SUTURE PACK  US1756 CUSTOM SUTURE PACK

## 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-1182-2023
- **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-1182-2023

## Citation

> AI Analytics. FDA recall Z-1182-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1182-2023. Source: US FDA. Licensed CC0.

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