--- title: "Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas ... — FDA record Z-0072-2023 | Is It on Recall" description: "Incidents of device splitting or detaching during use" url: https://isitonrecall.com/recall/fda-device-z-0072-2023-iso-gard-filter-s-ref-a-19211-ous-only-b-19212-microbial-medical-gas-filter-single-use-bacterial-vir/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filt... — FDA record Z-0072-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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**: Incidents of device splitting or detaching during use - **Classification**: Class I - **Recalling firm**: TELEFLEX LLC - **Quantity**: 60,500 units US - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0072-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0072-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a) 19211, UDI: (01)04026704347995(17)250528(10)19LT34, (01)04026704347995(17)250528(10)20FT02, (01)04026704347995(17)250528(10)20FT03, (01)04026704347995(17)250528(10)20FT06, (01)04026704347995(17)250528(10)20FT07, (01)04026704347995(17)250528(10)20FT13, (01)04026704347995(17)250528(10)20FT14, (01)04026704347995(17)250528(10)20FT16, (01)04026704347995(17)250528(10)20FT20, (01)04026704347995(17)250528(10)20FT22, (01)04026704347995(17)250528(10)20FT38, (01)04026704347995(17)250528(10)20FT41, (01)04026704347995(17)250528(10)20FT42, (01)04026704347995(17)250528(10)20FT50, (01)04026704347995(17)250528(10)20FT51, (01)04026704347995(17)250528(10)20FT56, (01)04026704347995(17)250528(10)20FT57, (01)04026704347995(17)250528(10)20FT62, (01)04026704347995(17)250528(10)20FT63, (01)04026704347995(17)250628(10)20FT67, (01)04026704347995(17)250628(10)20GT02, (01)04026704347995(17)250628(10)20GT03, (01)04026704347995(17)250628(10)20GT15, (01)04026704347995(17)250628(10)20GT17, (01)04026704347995(17)250628(10)20GT20, (01)04026704347995(17)250628(10)20GT21, (01)04026704347995(17)250628(10)20GT27, (01)04026704347995(17)250628(10)20GT28, (01)04026704347995(17)250628(10)20GT39, (01)04026704347995(17)250628(10)20GT46, (01)04026704347995(17)250628(10)20GT48, (01)04026704347995(17)250628(10)20GT53, (01)04026704347995(17)250628(10)20GT55, (01)04026704347995(17)250628(10)KMH20G0002, (01)04026704347995(17)250628(10)KMH20G0003, (01)04026704347995(17)250628(10)KMH20G0004, (01)04026704347995(17)250628(10)KMH20G0010, (01)04026704347995(17)250628(10)KMH20G0011, (01)04026704347995(17)250628(10)KMH20G0014, (01)04026704347995(17)250628(10)KMH20G0017, (01)04026704347995(17)250628(10)KMH20G0019, (01)04026704347995(17)250628(10)KMH20G0026, (01)04026704347995(17)250728(10)KMH20G0032, 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(01)04026704347995(17)251128(10)KMH20M0131, (01)04026704347995(17)251128(10)KMH20M0146, (01)04026704347995(17)251128(10)KMH20M0196, (01)04026704347995(17)251128(10)KMH20M0203, (01)04026704347995(17)251128(10)KMH20M0211, (01)04026704347995(17)251128(10)KMH20M0221, (01)04026704347995(17)251128(10)KMH20M0227, (01)04026704347995(17)251128(10)KMH20M0231, (01)04026704347995(17)251128(10)KMH20M0235, (01)04026704347995(17)251128(10)KMH20M0239, (01)04026704347995(17)251128(10)KMH20M0241, (01)04026704347995(17)251128(10)KMH20M0243, (01)0402670434... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0072-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US nationwide distribution States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Oct 26, 2022 - **Recall initiation date**: Aug 29, 2022 - **Center classification date**: Oct 14, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0072-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [TELEFLEX LLC records](https://isitonrecall.com/brand/teleflex-llc/)