Recall archive / FDA device enforcement
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS onl... — FDA record Z-0075-2023
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. Source coverage and dates.
What the record says
- 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,
- Reason
- Incidents of device splitting or detaching during use
- Classification
- Class I
- Recalling firm
- TELEFLEX LLC
- Quantity
- 355 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0075-2023
What the recall classes mean. 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) 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, UDI: (01)04026704400508(17)250528(10)202025, (01)04026704400508(17)250528(10)202026, (01)04026704400508(17)250628(10)202030, (01)04026704400508(17)250828(10)KMZ20J0163, (01)04026704400508(17)250828(10)KMZ20J0171, (01)04026704400508(17)250828(10)KMZ20J0582, (01)04026704400508(17)250828(10)KMZ20J0586, (01)04026704400508(17)250828(10)KMZ20J0587, (01)04026704400508(17)250928(10)KMZ20K0681, (01)04026704400508(17)251028(10)KMZ20L0968, (01)04026704400508(17)251028(10)KMZ20L0977, (01)04026704400508(17)251028(10)KMZ20L1275, (01)04026704400508(17)251128(10)KMZ20M0544, (01)04026704400508(17)251128(10)KMZ20M0661, (01)04026704400508(17)251228(10)KMZ21A0175, (01)04026704400508(17)251228(10)KMZ21A0186, (01)04026704400508(17)251228(10)KMZ21A0187, (01)04026704400508(17)251228(10)KMZ21A0208, (01)04026704400508(17)260128(10)KMZ21B0483, (01)04026704400508(17)260128(10)KMZ21B0485, (01)04026704400508(17)260128(10)KMZ21B0495, (01)04026704400508(17)260128(10)KMZ21B0811, (01)04026704400508(17)260128(10)KMZ21B0918, (01)04026704400508(17)260128(10)KMZ21B1172, (01)04026704400508(17)260228(10)KMZ21C0884, (01)04026704400508(17)260228(10)KMZ21C0910, (01)04026704400508(17)260228(10)KMZ21C0929, (01)04026704400508(17)260228(10)KMZ21C0931, (01)04026704400508(17)260328(10)KMZ21D0419, (01)04026704400508(17)260528(10)KMZ21F0223, (01)04026704400508(17)260528(10)KMZ21F0260, (01)04026704400508(17)260528(10)KMZ21F0528, (01)04026704400508(17)260628(10)KMZ21G0728, (01)04026704400508(17)260628(10)KMZ21G0735, (01)04026704400508(17)260628(10)KMZ21G0739, (01)04026704400508(17)260728(10)KMZ21H0055, (01)04026704400508(17)260828(10)KMZ21J0006, (01)04026704400508(17)260828(10)KMZ21J0007, (01)04026704400508(17)260828(10)KMZ21J0008, (01)04026704400508(17)260928(10)KMZ21K0510, (01)04026704400508(17)260928(10)KMZ21K0524, (01)04026704400508(17)260928(10)KMZ21K0539, (01)04026704400508(17)260928(10)KMZ21K0572, (01)04026704400508(17)260928(10)KMZ21K0578, (01)04026704400508(17)260928(10)KMZ21K0592, (01)04026704400508(17)260928(10)KMZ21K0952, (01)04026704400508(17)261028(10)KMZ21L0218, (01)04026704400508(17)261128(10)KMZ21M0674, (01)04026704400508(17)270128(10)KMZ22B0125, (01)04026704400508(17)270128(10)KMZ22B0345, (01)04026704400508(17)270128(10)KMZ22B0809, (01)04026704400508(17)270128(10)KMZ22B0828, (01)04026704400508(17)270128(10)KMZ22B0838, (01)04026704400508(17)270128(10)KMZ22B0869, (01)04026704400508(17)270228(10)KMZ22C0659; c) 19272T, UDI: (01)04026704400515(17)250528(10)202025, (01)04026704400515(17)250528(10)202026, (01)04026704400515(17)250628(10)202027, (01)04026704400515(17)250628(10)202028, (01)04026704400515(17)250628(10)202029, (01)04026704400515(17)250628(10)202030, (01)04026704400515(17)250628(10)202031, (01)04026704400515(17)250628(10)KMZ20G0005, (01)04026704400515(17)250628(10)KMZ20G0026, (01)04026704400515(17)250628(10)KMZ20G0105, (01)04026704400515(17)250628(10)KMZ20G0112, (01)04026704400515(17)250728(10)KMZ20H0081, (01)04026704400515(17)250728(10)KMZ20H0096, (01)04026704400515(17)250728(10)KMZ20H0158, (01)04026704400515(17)250728(10)KMZ20H0379, (01)04026704400515(17)250728(10)KMZ20H0530, (01)04026704400515(17)250728(10)KMZ20H0540, (01)04026704400515(17)250728(10)KMZ20H0564, (01)04026704400515(17)250728(10)KMZ20H0812, (01)04026704400515(17)250728(10)KMZ20H0841, (01)04026704400515(17)250728(10)KMZ20H1021, (01)04026704400515(17)250728(10)KMZ20H1024, (01)04026704400515(17)250728(10)KMZ20H1031, (01)04026704400515(17)250828(10)KMZ20J0092, (01)04026704400515(17)250828(10)KMZ20J0102, (01)04026704400515(17)250828(10)KMZ20J0227, (01)04026704400515(17)250828(10)KMZ20J0441, (01)04026704400515(17)250828(10)KMZ20J0535, (01)04026704400515(17)250828(10)KMZ20J0551, (01)04026704400515(17)250828(10)KMZ20J0566, (01)04026704400515(17)250828(10)KMZ20J0640, (01)04026704400515(17)250828(10)KMZ20J0654, (01)04026704400515(17)250828(10)KMZ20J0663, (01)04026704400515(17)250828(10)KMZ20J0893, (01)04026704400515(17)250828(10)KMZ20J0958, (01)04026704400515(17)250928(10)KMZ20K0034, (01)04026704400515(17)250928(10)KMZ20K0196, (01)04026704400515(17)250928(10)KMZ20K0236, (01)04026704400515(17)250928(10)KMZ20K0430, (01)04026704400515(17)250928(10)KMZ20K0659, (01)04026704400515(17)250928(10)KMZ20K0662, (01)04026704400515(17)250928(10)KMZ20K0838, (01)04026704400515(17)250928(10)KMZ20K0946, (01)04026704400515(17)250928(10)KMZ20K1260, (01)04026704400515(17)250928(10)KMZ20K1289, (01)04026704400515(17)250928(10)KMZ20K1294, (01)04026704400515(17)250928(10)KMZ20K1310, (01)04026704400515(17)250928(10)KMZ20K1339, (01)04026704400515(17)250928(10)KMZ20K1340, (01)04026704400515(17)251028(10)KMZ20L0003, (01)04026704400515(17)251028(10)KMZ20L0030, (01)04026704400515(17)251028(10)KMZ20L0031, (01)04026704400515(17)251028(10)KMZ20L0117, (01)04026704400515(17)251028(10)KMZ20L0214, (01)04026704400515(17)251028(10)KMZ20L0351, (01)04026704400515(17)251028(10)KMZ20L0359, (01)04026704400515(17)251028(10)KMZ20L0499, (01)04026704400515(17)251028(10)KMZ20L0537, (01)04026704400515(17)251028(10)KMZ20L0706, (01)04026704400515(17)251028(10)KMZ20L0724, (01)04026704400515(17)251028(10)KMZ20L0885, (01)04026704400515(17)251028(10)KMZ20L0886, (01)04026704400515(17)251028(10)KMZ20L0933, (01)04026704400515(17)251028(10)KMZ20L0945, (01)04026704400515(17)251028(10)KMZ20L1056, (01)04026704400515(17)251028(10)KMZ20L1091, (01)04026704400515(17)251028(10)KMZ20L1103, (01)04026704400515(17)251028(10)KMZ20L1104, (01)04026704400515(17)251128(10)KMZ20M0387, (01)04026704400515(17)251128(10)KMZ20M0777, (01)04026704400515(17)251128(10)KMZ20M0778, (01)04026704400515(17)251128(10)KMZ20M0787, (01)04026704400515(17)251128(10)KMZ20M0822, (01)04026704400515(17)251128(10)KMZ20M0842, (01)04026704400515(17)251128(10)KMZ20M0938, (01)04026704400515(17)251128(10)KMZ20M0967, (01)04026704400515(17)251128(10)KMZ20M0990, (01)04026704400515(17)251128(10)KMZ20M1249, (01)04026704400515(17)251128(10)KMZ20M1250, (01)04026704400515(17)251128(10)KMZ20M1257, (01)04026704400515(17)251128(10)KMZ20M1267, (01)04026704400515(17)251228(10)KMZ21A0012, (01)04026704400515(17)251228(10)KMZ21A0024, (01)04026704400515(17)251228(10)KMZ21A0117, (01)04026704400515(17)251228(10)KMZ21A0126, (01)04026704400515(17)251228(10)KMZ21A0155, (01)04026704400515(17)251228(10)KMZ21A0162, (01)04026704400515(17)251228(10)KMZ21A0164, (01)04026704400515(17)251228(10)KMZ21A0203, (01)04026704400515(17)251228(10)KMZ21A0218, (01)04026704400515(17)251228(10)KMZ21A0226, (01)04026704400515(17)251228(10)KMZ21A0368, (01)04026704400515(17)251228(10)KMZ21A0618, (01)04026704400515(17)251228(10)KMZ21A0635, (01)04026704400515(17)251228(10)KMZ21A0693, (01)04026704400515(17)251228(10)KMZ21A0706, (01)04026704400515(17)251228(10)KMZ21A0714, (01)04026704400515(17)251228(10)KMZ21A0725, (01)04026704400515(17)251228(10)KMZ21A0734, (01)04026704400515(17)251228(10)KMZ21A0950, (01)04026704400515(17)260128(10)KMZ21B0101, (01)04026704400515(17)260128(10)KMZ21B0163, (01)04026704400515(17)260128(10)KMZ21B0181, (01)04026704400515(17)260128(10)KMZ21B0183, (01)04026704400515(17)260128(10)KMZ21B0185, (01)04026704400515(17)260128(10)KMZ21B0189, (01)04026704400515(17)260128(10)KMZ21B0227, (01)04026704400515(17)260128(10)KMZ21B0234, (01)04026704400515(17)260128(10)KMZ21B0305, (01)04026704400515(17)260128(10)KMZ21B0320, (01)04026704400515(17)260128(10)KMZ21B0417, (01)04026704400515(17)260128(10)KMZ21B0421, (01)04026704400515(17)260128(10)KMZ21B0435, (01)04026704400515(17)260128(10)KMZ21B0465, (01)04026704400515(17)260128(10)KMZ21B0471, (01)04026704400515(17)260128(10)KMZ21B0479, (01)04026704400515(17)260128(10)KMZ21B0533, (01)04026704400515(17)260128(10)KMZ21B0689, (01)04026704400515(17)260128(10)KMZ21B1171, (01)04026704400515(17)260228(10)KMZ21C0270, (01)04026704400515(17)260228(10)KMZ21C0388, (01)04026704400515(17)260228(10)KMZ21C0398, (01)04026704400515(17)260228(10)KMZ21C0883, (01)04026704400515(17)260228(10)KMZ21C1159, (01)04026704400515(17)260228(10)KMZ21C1160, (01)04026704400515(17)260228(10)KMZ21C1358, (01)04026704400515(17)260328(10)KMZ21D0420, (01)04026704400515(17)260528(10)KMZ21F0227, (01)04026704400515(17)260528(10)KMZ21F0265, (01)04026704400515(17)260528(10)KMZ21F0296, (01)04026704400515(17)260528(10)KMZ21F0335, (01)04026704400515(17)260528(10)KMZ21F0375, (01)04026704400515(17)260528(10)KMZ21F0430, (01)04026704400515(17)260528(10)KMZ21F0467, (01)04026704400515(17)260528(10)KMZ21F0468, (01)04026704400515(17)260528(10)KMZ21F0478, (01)04026704400515(17)260528(10)KMZ21F0501, (01)04026704400515(17)260528(10)KMZ21F0517, (01)04026704400515(17)260528(10)KMZ21F0534, (01)04026704400515(17)260528(10)KMZ21F0550, (01)04026704400515(17)260528(10)KMZ21F0551, (01)04026704400515(17)260528(10)KMZ21F0552, (01)04026704400515(17)260528(10)KMZ21F0557, (01)04026704400515(17)260528(10)KMZ21F0567, (01)04026704400515(17)260528(10)KMZ21F0568, (01)04026704400515(17)260528(10)KMZ21F0588, (01)04026704400515(17)260528(10)KMZ21F0594, (01)04026704400515(17)260528(10)KMZ21F0742, (01)04026704400515(17)260528(10)KMZ21F0777, (01)04026704400515(17)260628(10)KMZ21G0399, (01)04026704400515(17)260628(10)KMZ21G0403, (01)04026704400515(17)260628(10)KMZ21G0404, (01)04026704400515(17)260628(10)KMZ21G0751, (01)04026704400515(17)260628(10)KMZ21G0765, (01)04026704400515(17)260628(10)KMZ21G0770, (01)04026704400515(17)260628(10)KMZ21G0778, (01)04026704400515(17)260628(10)KMZ21G0786, (01)04026704400515(17)260628(10)KMZ21G0800, (01)04026704400515(17)260628(10)KMZ21G0806, (01)04026704400515(17)260628(10)KMZ21G0838, (01)04026704400515(17)260628(10)KMZ21G0911, (01)04026704400515(17)260628(10)KMZ21G0912, (01)04026704400515(17)260628(10)KMZ21G0917, (01)04026704400515(17)260628(10)KMZ21G0954, (01)04026704400515(17)260628(10)KMZ21G0955, (01)04026704400515(17)260628(10)KMZ21G0956, (01)04026704400515(17)260628(10)KMZ21G0964, (01)04026704400515(17)260628(10)KMZ21G0971, (01)04026704400515(17)260628(10)KMZ21G0982, (01)04026704400515(17)260628(10)KMZ21G0986, (01)04026704400515(17)260628(10)KMZ21G0992, (01)04026704400515(17)260628(10)KMZ21G0993, (01)04026704400515(17)260628(10)KMZ21G0995, (01)04026704400515(17)260628(10)KMZ21G1001, (01)04026704400515(17)260628(10)KMZ21G1008, (01)04026704400515(17)260628(10)KMZ21G1017, (01)04026704400515(17)260628(10)KMZ21G1037, (01)04026704400515(17)260628(10)KMZ21G1038, (01)04026704400515(17)260728(10)KMZ21H0115, (01)04026704400515(17)260728(10)KMZ21H0257, (01)04026704400515(17)260728(10)KMZ21H0299, (01)04026704400515(17)260728(10)KMZ21H0405, (01)04026704400515(17)260728(10)KMZ21H0429, (01)04026704400515(17)260728(10)KMZ21H0431, (01)04026704400515(17)260728(10)KMZ21H0433, (01)04026704400515(17)260728(10)KMZ21H0435, (01)04026704400515(17)260728(10)KMZ21H0504, (01)04026704400515(17)260728(10)KMZ21H0508, (01)04026704400515(17)260728(10)KMZ21H0526, (01)04026704400515(17)260728(10)KMZ21H0560, (01)04026704400515(17)260728(10)KMZ21H0561, (01)04026704400515(17)260828(10)KMZ21J0050, (01)04026704400515(17)260828(10)KMZ21J0077, (01)04026704400515(17)260828(10)KMZ21J0088, (01)04026704400515(17)260828(10)KMZ21J0089, (01)04026704400515(17)260828(10)KMZ21J0446, (01)04026704400515(17)260828(10)KMZ21J0447, (01)04026704400515(17)260828(10)KMZ21J0448, (01)04026704400515(17)260828(10)KMZ21J0484, (01)04026704400515(17)260... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
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
- Alabama
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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.