The Recall Desk
SevereFDA (Devices)·Z-0075-2023·Announced 2022-10-26

Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I medical device recall, the highest severity category. Incidents of device splitting or detaching during use represent serious mechanical failure that could interrupt or compromise medical gas delivery, though no specific illnesses or injuries are reported in the available source material.

Plain-English summary

TELEFLEX LLC is recalling 355 units of the Iso-Gard Filter S medical gas filter with Expandi-Flex and Tethered Cap (model numbers 19261T, 19262T, and 19272T). This is a single-use microbial medical gas filter used in healthcare settings.

The recall addresses incidents in which the filter device splits or detaches during use. This device failure poses a serious risk during medical gas delivery applications.

The filters were distributed nationwide in the United States. Healthcare facilities and providers using this product should cease use, inspect affected units, and contact TELEFLEX LLC for guidance on replacement or return. Consumers can reference the specific model numbers, lot codes, and UDI information available from the FDA's recall database.

The recalled product

Product
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory Gas Filter
Hazard
Affected units
355

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) 19261T
  • UDI: (01)04026704400492(17)250528(10)20FT51
  • (01)04026704400492(17)251028(10)KMH20L0409
  • (01)04026704400492(17)251228(10)KMH21A0086
  • (01)04026704400492(17)251228(10)KMH21A0190
  • (01)04026704400492(17)260128(10)KMH21B0163
  • (01)04026704400492(17)260128(10)KMH21B0343
  • (01)04026704400492(17)260128(10)KMH21B0355
  • (01)04026704400492(17)260228(10)KMH21C0177
  • (01)04026704400492(17)260228(10)KMH21C0387
  • (01)04026704400492(17)260528(10)KMH21F0156
  • (01)04026704400492(17)260528(10)KMH21F0337
  • (01)04026704400492(17)260628(10)KMH21G0426
  • (01)04026704400492(17)260828(10)KMH21J0020
  • (01)04026704400492(17)260828(10)KMH21J0245
  • (01)04026704400492(17)260928(10)KMH21K0142
  • (01)04026704400492(17)261128(10)KMH21M0182
  • (01)04026704400492(17)270128(10)KMH22B0151
  • (01)04026704400492(17)270128(10)KMH22B0248
  • b) 19262T

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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