# FDA recall Z-1175-2023

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

## Product

Novafil Monofilament Polybutester Suture  Product Description:   8886 4002-41 NOVAFIL 3-0 BLU 90CM C14  8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2  8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2  8886 440123 NOVAFIL 5-0 BLU 45CM SBE3  8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4  8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6  8886 4410-13 NOVAFIL 6-0 BLU 45CM P10  8886 4410-03 NOVAFIL 7-0 BLU 45CM P10  8886 4422-43 NOVAFIL 3-0 BLU 45CM C14  8886 4424-51 NOVAFIL 2-0 BLU 75CM C16  8886 4450-41 NOVAFIL 3-0 BLU 75CM V26  8886 4452-51 NOVAFIL 2-0 BLU 75CM V20  8886 4459-61 NOVAFIL 0 BLU 75CM GS22  8886 4470-81 NOVAFIL* 2 BLU 150CM GS26  8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14  SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12  SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12  SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12  SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12  SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12  SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13  SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12  SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12

## 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-1175-2023
- **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-1175-2023

## Citation

> AI Analytics. FDA recall Z-1175-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1175-2023. Source: US FDA. Licensed CC0.

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