Teleflex recalls Iso-Gard Filter S with Expandi-Flex Tethered Cap (models 19261T, 19262T, 19272T) sold only in OUS. Incidents of device splitting or detaching during use reported.
Incidents of device splitting or detaching during use
Teleflex is recalling Iso-Gard Filter S devices with Expandi-Flex Tethered Cap (models 19261T, 19262T, 19272T) sold only in OUS. These devices have been reported to split or detach during use, which could cause injury.
The device can split or detach during use, potentially causing injury. This is a mechanical failure that could lead to the filter becoming dislodged or damaged.
Users of medical gas filters in OUS (outside the U.S.) who own the recalled models. Healthcare providers using these filters are most at risk.
Check for the model numbers 19261T, 19262T, or 19272T on the device. These filters were sold only in OUS (outside the U.S.).
Look for the model number on the device: 19261T, 19262T, or 19272T.
If you have the recalled model, contact Teleflex for instructions on how to handle the device.
No, these filters were sold only in OUS (outside the U.S.).
Contact Teleflex for instructions on how to handle the device.
Yes, the device has been reported to split or detach during use, which could cause injury.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-0075-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-0075-2023 from Teleflex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
