# FDA recall Z-0072-2023

> **TELEFLEX LLC** · Class I · device recall initiated 2022-08-29.

## Product

Iso-Gard Filter S, REF :  a)  19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

## Reason for recall

Incidents of device splitting or detaching during use

## Distribution

US nationwide distribution

## Key facts

- **Recall number:** Z-0072-2023
- **Recalling firm:** TELEFLEX LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-29
- **Report date:** 2022-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2023

## Citation

> AI Analytics. FDA recall Z-0072-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0072-2023. Source: US FDA. Licensed CC0.

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