Iso-Gard Respiratory Filter Recall Over Splitting Filters Following Injury Reports

More than 60,000 Teleflex Iso-Gard Filter S devices are being recalled due to a risk they may lead to breathing problems and low oxygen levels in patients.

The FDA announced the Iso-Gard Filter S recall on November 1, giving it a Class I recall designation, meaning the agency believes problems with the devices could lead to serious injuries or deaths.

Teleflex, the manufacturer, indicates it has received at least 36 complaints involving problems with the filters, and there have been at least four injuries, with some due to desaturation.

The Iso-Gard Filter S is a breathing circuit bacterial filter which connects to breathing equipment or respiratory systems in intensive care units (ICU) and operating rooms. The filters prevent potential airborne contaminants from harming patients or damaging the equipment.

On August 29, Teleflex, Inc. sent an Urgent Medical Device Recall letter to customers, warning that the filters may split or detach from breathing systems, which may lead to breathing problems in patients, including an insufficient supply of air which could lead patients’ oxygen levels to drop below safe levels, known as desaturation, and could lead to cross-contamination.

The recent class I designation by the FDA is the strongest recall classification the agency can give, indicating the problems with the filters can cause serious injuries or death. However, no deaths have been reported in connection to the recalled filters.

The recall affects 60,500 Iso-Gard Filter S devices distributed between September 1, 2020 and July 5, 2022. A full list of affected devices is available here.

In the original letter, Teleflex urged medical facilities to stop using the affected filters, quarantine the devices, and contact Teleflex to return affect products and receive a refund.

Customers and healthcare providers with questions regarding this recall should contact Teleflex customer service by telephone at 1-866-396-2111.

Customers who have experienced health problems or side effects linked to the Teleflex Iso-Gard Filter S recall can report them to the FDA’s MedWatch Adverse Event Reporting program.