Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012 Recalled by TELEFLEX LLC Due to Incidents of device splitting or detaching during use

Date: August 29, 2022
Company: TELEFLEX LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact TELEFLEX LLC directly.

Affected Products

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Quantity: 42 units

Why Was This Recalled?

Incidents of device splitting or detaching during use

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TELEFLEX LLC

TELEFLEX LLC has 139 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report