--- title: "Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS onl... — FDA record Z-0074-2023 | Is It on Recall" description: "Incidents of device splitting or detaching during use" url: https://isitonrecall.com/recall/fda-device-z-0074-2023-iso-gard-filter-s-tethered-cap-ref-a-19211t-ous-only-b-19212t-ous-only-microbial-medical-gas-filter/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use — FDA record Z-0074-2023 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, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use - **Reason**: Incidents of device splitting or detaching during use - **Classification**: Class I - **Recalling firm**: TELEFLEX LLC - **Quantity**: 164 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0074-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0074-2023%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) 19211T, UDI: (01)04026704400478(17)250528(10)20FT38, (01)04026704400478(17)250628(10)20FT63, (01)04026704400478(17)250728(10)20GT03, (01)04026704400478(17)250828(10)KMH20H0303, (01)04026704400478(17)251028(10)KMH20J0148, (01)04026704400478(17)251028(10)KMH20L0135, (01)04026704400478(17)251028(10)KMH20L0137, (01)04026704400478(17)251128(10)KMH20L0362, (01)04026704400478(17)251128(10)KMH20M0236, (01)04026704400478(17)251128(10)KMH20M0276, (01)04026704400478(17)251228(10)KMH20M0477, (01)04026704400478(17)260228(10)KMH21A0397, (01)04026704400478(17)260828(10)KMH21C0228, (01)04026704400478(17)260928(10)KMH21J0146, (01)04026704400478(17)260928(10)KMH21K0122, (01)04026704400478(17)260928(10)KMH21K0130, (01)04026704400478(17)260928(10)KMH21K0133, (01)04026704400478(17)260928(10)KMH21K0137, (01)04026704348008(17)241128(10)KMH21K0155; b) 19212T, UDI: (01)04026704400485(17)250528(10)202025, (01)04026704400485(17)250528(10)202026, (01)04026704400485(17)250628(10)202027, (01)04026704400485(17)250628(10)202029, (01)04026704400485(17)250628(10)202030, (01)04026704400485(17)250728(10)KMZ20H0321, (01)04026704400485(17)250728(10)KMZ20H0341, (01)04026704400485(17)250728(10)KMZ20H0407, (01)04026704400485(17)250728(10)KMZ20H0519, (01)04026704400485(17)250728(10)KMZ20H0602, (01)04026704400485(17)250728(10)KMZ20H0619, (01)04026704400485(17)250728(10)KMZ20H0785, (01)04026704400485(17)250728(10)KMZ20H0792, (01)04026704400485(17)250728(10)KMZ20H0804, (01)04026704400485(17)250728(10)KMZ20H1025, (01)04026704400485(17)250728(10)KMZ20H1026, (01)04026704400485(17)250828(10)KMZ20J0386, (01)04026704400485(17)250828(10)KMZ20J0428, (01)04026704400485(17)250828(10)KMZ20J0466, (01)04026704400485(17)250828(10)KMZ20J0475, (01)04026704400485(17)250928(10)KMZ20K0161, (01)04026704400485(17)250928(10)KMZ20K0436, (01)04026704400485(17)250928(10)KMZ20K0478, (01)04026704400485(17)250928(10)KMZ20K0526, (01)04026704400485(17)250928(10)KMZ20K0527, (01)04026704400485(17)250928(10)KMZ20K0799, (01)04026704400485(17)250928(10)KMZ20K0917, (01)04026704400485(17)250928(10)KMZ20K1295, (01)04026704400485(17)250928(10)KMZ20K1311, (01)04026704400485(17)251028(10)KMZ20L0144, (01)04026704400485(17)251028(10)KMZ20L0160, (01)04026704400485(17)251028(10)KMZ20L0338, (01)04026704400485(17)251028(10)KMZ20L0350, (01)04026704400485(17)251028(10)KMZ20L0912, (01)04026704400485(17)251028(10)KMZ20L0926, (01)04026704400485(17)251028(10)KMZ20L0927, (01)04026704400485(17)251028(10)KMZ20L0928, (01)04026704400485(17)251028(10)KMZ20L0944, (01)04026704400485(17)251128(10)KMZ20M0411, (01)04026704400485(17)251128(10)KMZ20M1224, (01)04026704400485(17)251228(10)KMZ21A0011, (01)04026704400485(17)251228(10)KMZ21A0214, (01)04026704400485(17)251228(10)KMZ21A0301, (01)04026704400485(17)251228(10)KMZ21A0369, (01)04026704400485(17)251228(10)KMZ21A0419, (01)04026704400485(17)251228(10)KMZ21A0533, (01)04026704400485(17)251228(10)KMZ21A0807, (01)04026704400485(17)251228(10)KMZ21A0867, (01)04026704400485(17)251228(10)KMZ21A1017, (01)04026704400485(17)260128(10)KMZ21B0688, (01)04026704400485(17)260128(10)KMZ21B1032, (01)04026704400485(17)260128(10)KMZ21B1156, (01)04026704400485(17)260128(10)KMZ21B1188, (01)04026704400485(17)260228(10)KMZ21C0712, (01)04026704400485(17)260228(10)KMZ21C0760, (01)04026704400485(17)260228(10)KMZ21C0882, (01)04026704400485(17)260228(10)KMZ21C1163, (01)04026704400485(17)260228(10)KMZ21C1329, (01)04026704400485(17)260328(10)KMZ21D0390, (01)04026704400485(17)260328(10)KMZ21D0394, (01)04026704400485(17)260328(10)KMZ21D0400, (01)04026704400485(17)260328(10)KMZ21D0518, (01)04026704400485(17)260328(10)KMZ21D0534, (01)04026704400485(17)260328(10)KMZ21D1020, (01)04026704400485(17)260328(10)KMZ21D1051, (01)04026704400485(17)260428(10)KMZ21E0245, (01)04026704400485(17)260428(10)KMZ21E0253, (01)04026704400485(17)260428(10)KMZ21E0420, (01)04026704400485(17)260528(10)KMZ21F0202, (01)04026704400485(17)260528(10)KMZ21F0206, (01)04026704400485(17)260528(10)KMZ21F0217, (01)04026704400485(17)260528(10)KMZ21F0339, (01)04026704400485(17)260528(10)KMZ21F0438, (01)04026704400485(17)260528(10)KMZ21F0773, (01)04026704400485(17)260528(10)KMZ21F0786, (01)04026704400485(17)260628(10)KMZ21G0060, (01)04026704400485(17)260628(10)KMZ21G0353, (01)04026704400485(17)260628(10)KMZ21G0360, (01)04026704400485(17)260628(10)KMZ21G0392, (01)04026704400485(17)260728(10)KMZ21H0410, (01)04026704400485(17)260728(10)KMZ21H0424, (01)04026704400485(17)260728(10)KMZ21H0534, (01)04026704400485(17)260728(10)KMZ21H0538, (01)04026704400485(17)260828(10)KMZ21J0036, (01)04026704400485(17)260828(10)KMZ21J0321, (01)04026704400485(17)260828(10)KMZ21J0338, (01)04026704400485(17)260828(10)KMZ21J0403, (01)04026704400485(17)260828(10)KMZ21J0407, (01)04026704400485(17)260828(10)KMZ21J0428, (01)04026704400485(17)260828(10)KMZ21J0435, (01)04026704400485(17)260928(10)KMZ21K0028, (01)04026704400485(17)260928(10)KMZ21K0113, (01)04026704400485(17)260928(10)KMZ21K0191, (01)04026704400485(17)260928(10)KMZ21K0223, (01)04026704400485(17)260928(10)KMZ21K0230, (01)04026704400485(17)260928(10)KMZ21K0239, (01)04026704400485(17)260928(10)KMZ21K0260, (01)04026704400485(17)260928(10)KMZ21K0329, (01)04026704400485(17)260928(10)KMZ21K0381, (01)04026704400485(17)260928(10)KMZ21K0391, (01)04026704400485(17)260928(10)KMZ21K0403, (01)04026704400485(17)260928(10)KMZ21K0438, (01)04026704400485(17)260928(10)KMZ21K0457, (01)04026704400485(17)260928(10)KMZ21K0498, (01)04026704400485(17)260928(10)KMZ21K0552, (01)04026704400485(17)260928(10)KMZ21K0562, (01)04026704400485(17)260928(10)KMZ21K0579, (01)04026704400485(17)260928(10)KMZ21K0610, (01)04026704400485(17)261028(10)KMZ21L0114, (01)04026704400485(17)261028(10)KMZ21L0209, (01)04026704400485(17)261028(10)KMZ21L0321, (01)04026704400485(17)261028(10)KMZ21L0536, (01)04026704400485(17)261028(10)KMZ21L0665, (01)04026704400485(17)261128(10)KMZ21M0066, (01)04026704400485(17)261128(10)KMZ21M0476, (01)04026704400485(17)261128(10)KMZ21M0486, (01)04026704400485(17)261128(10)KMZ21M0526, (01)04026704400485(17)261128(10)KMZ21M0572, (01)04026704400485(17)261128(10)KMZ21M0586, (01)04026704400485(17)261128(10)KMZ21M0601, (01)04026704400485(17)261128(10)KMZ21M0606, (01)04026704400485(17)261128(10)KMZ21M0658, (01)04026704400485(17)261128(10)KMZ21M0742, (01)04026704400485(17)261128(10)KMZ21M0775, (01)04026704400485(17)261228(10)KMZ22A0035, (01)04026704400485(17)261228(10)KMZ22A0059, (01)04026704400485(17)261228(10)KMZ22A0076, (01)04026704400485(17)261228(10)KMZ22A0085, (01)04026704400485(17)261228(10)KMZ22A0471, (01)04026704400485(17)261228(10)KMZ22A0482, (01)04026704400485(17)261228(10)KMZ22A0483, (01)04026704400485(17)270128(10)KMZ22B0043, (01)04026704400485(17)270128(10)KMZ22B0044, (01)04026704400485(17)270128(10)KMZ22B0123, (01)04026704400485(17)270128(10)KMZ22B0439, (01)04026704400485(17)270128(10)KMZ22B0480, (01)04026704400485(17)270128(10)KMZ22B0783, (01)04026704400485(17)270128(10)KMZ22B0871, (01)04026704400485(17)270228(10)KMZ22C0231, (01)04026704400485(17)270228(10)KMZ22C0398, (01)04026704400485(17)270228(10)KMZ22C0444, (01)04026704400485(17)270228(10)KMZ22C0606, (01)04026704400485(17)270228(10)KMZ22C0611, (01)04026704400485(17)270228(10)KMZ22C0616, (01)04026704400485(17)270228(10)KMZ22C0624. | 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. 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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-0074-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [TELEFLEX LLC records](https://isitonrecall.com/brand/teleflex-llc/)