Z-1177-2023 Class II Ongoing
FDA device recall Z-1177-2023 was initiated by Covidien, LP on Dec 2, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 2070 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 8, 2023
- Initiation Date
- Dec 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2070 units
Product Description
Reason for Recall
Distribution Pattern
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
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1177-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026