Recall archive / 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. Source coverage and dates.
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
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) 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, (01)04026704347995(17)250728(10)KMH20H0005, (01)04026704347995(17)250728(10)KMH20H0011, (01)04026704347995(17)250728(10)KMH20H0015, (01)04026704347995(17)250728(10)KMH20H0017, (01)04026704347995(17)250728(10)KMH20H0019, (01)04026704347995(17)250728(10)KMH20H0028, (01)04026704347995(17)250728(10)KMH20H0035, (01)04026704347995(17)250728(10)KMH20H0038, (01)04026704347995(17)250728(10)KMH20H0053, (01)04026704347995(17)250728(10)KMH20H0086, (01)04026704347995(17)250728(10)KMH20H0099, (01)04026704347995(17)250728(10)KMH20H0105, (01)04026704347995(17)250728(10)KMH20H0112, (01)04026704347995(17)250728(10)KMH20H0132, (01)04026704347995(17)250728(10)KMH20H0159, (01)04026704347995(17)250728(10)KMH20H0165, (01)04026704347995(17)250728(10)KMH20H0167, (01)04026704347995(17)250728(10)KMH20H0174, (01)04026704347995(17)250728(10)KMH20H0179, (01)04026704347995(17)250728(10)KMH20H0180, (01)04026704347995(17)250728(10)KMH20H0182, (01)04026704347995(17)250728(10)KMH20H0184, (01)04026704347995(17)250728(10)KMH20H0189, (01)04026704347995(17)250728(10)KMH20H0194, (01)04026704347995(17)250728(10)KMH20H0229, (01)04026704347995(17)250728(10)KMH20H0231, (01)04026704347995(17)250728(10)KMH20H0232, (01)04026704347995(17)250728(10)KMH20H0233, (01)04026704347995(17)250728(10)KMH20H0235, (01)04026704347995(17)250728(10)KMH20H0252, (01)04026704347995(17)250728(10)KMH20H0254, (01)04026704347995(17)250728(10)KMH20H0257, (01)04026704347995(17)250728(10)KMH20H0266, (01)04026704347995(17)250728(10)KMH20H0268, (01)04026704347995(17)250728(10)KMH20H0270, (01)04026704347995(17)250728(10)KMH20H0290, (01)04026704347995(17)250728(10)KMH20H0295, (01)04026704347995(17)250728(10)KMH20H0298, (01)04026704347995(17)250728(10)KMH20H0299, (01)04026704347995(17)250728(10)KMH20H0301, (01)04026704347995(17)250728(10)KMH20H0302, (01)04026704347995(17)250728(10)KMH20H0307, (01)04026704347995(17)250728(10)KMH20H0312, (01)04026704347995(17)250728(10)KMH20H0313, (01)04026704347995(17)250728(10)KMH20H0316, (01)04026704347995(17)250728(10)KMH20H0318, (01)04026704347995(17)250828(10)KMH20H0319, (01)04026704347995(17)250828(10)KMH20J0001, (01)04026704347995(17)250828(10)KMH20J0018, (01)04026704347995(17)250828(10)KMH20J0023, (01)04026704347995(17)250828(10)KMH20J0030, (01)04026704347995(17)250828(10)KMH20J0037, (01)04026704347995(17)250828(10)KMH20J0038, (01)04026704347995(17)250828(10)KMH20J0042, (01)04026704347995(17)250828(10)KMH20J0047, (01)04026704347995(17)250828(10)KMH20J0052, (01)04026704347995(17)250828(10)KMH20J0054, (01)04026704347995(17)250828(10)KMH20J0067, (01)04026704347995(17)250828(10)KMH20J0071, (01)04026704347995(17)250828(10)KMH20J0072, (01)04026704347995(17)250828(10)KMH20J0075, (01)04026704347995(17)250828(10)KMH20J0076, (01)04026704347995(17)250828(10)KMH20J0079, (01)04026704347995(17)250828(10)KMH20J0082, (01)04026704347995(17)250828(10)KMH20J0086, (01)04026704347995(17)250828(10)KMH20J0091, (01)04026704347995(17)250828(10)KMH20J0094, (01)04026704347995(17)250828(10)KMH20J0097, (01)04026704347995(17)250828(10)KMH20J0098, (01)04026704347995(17)250828(10)KMH20J0100, (01)04026704347995(17)250828(10)KMH20J0111, (01)04026704347995(17)250828(10)KMH20J0113, (01)04026704347995(17)250828(10)KMH20J0119, (01)04026704347995(17)250828(10)KMH20J0130, (01)04026704347995(17)250828(10)KMH20J0131, (01)04026704347995(17)250828(10)KMH20J0132, (01)04026704347995(17)250828(10)KMH20J0136, (01)04026704347995(17)250828(10)KMH20J0150, (01)04026704347995(17)250828(10)KMH20J0154, (01)04026704347995(17)250828(10)KMH20J0159, (01)04026704347995(17)250828(10)KMH20J0169, (01)04026704347995(17)250828(10)KMH20J0171, (01)04026704347995(17)250828(10)KMH20J0195, (01)04026704347995(17)250828(10)KMH20J0198, (01)04026704347995(17)250828(10)KMH20J0202, (01)04026704347995(17)250828(10)KMH20J0204, (01)04026704347995(17)250828(10)KMH20J0214, (01)04026704347995(17)250828(10)KMH20J0232, (01)04026704347995(17)250828(10)KMH20J0252, (01)04026704347995(17)250828(10)KMH20J0256, (01)04026704347995(17)250828(10)KMH20J0259, (01)04026704347995(17)250828(10)KMH20J0262, (01)04026704347995(17)250828(10)KMH20J0271, (01)04026704347995(17)250828(10)KMH20J0274, (01)04026704347995(17)250828(10)KMH20J0284, (01)04026704347995(17)250828(10)KMH20J0286, (01)04026704347995(17)250828(10)KMH20J0288, (01)04026704347995(17)250828(10)KMH20J0289, (01)04026704347995(17)250828(10)KMH20J0292, (01)04026704347995(17)250828(10)KMH20J0297, (01)04026704347995(17)250828(10)KMH20J0299, (01)04026704347995(17)250828(10)KMH20J0305, (01)04026704347995(17)250828(10)KMH20J0314, (01)04026704347995(17)250828(10)KMH20J0316, (01)04026704347995(17)250828(10)KMH20J0318, (01)04026704347995(17)250828(10)KMH20J0320, (01)04026704347995(17)250828(10)KMH20J0321, (01)04026704347995(17)250828(10)KMH20J0325, (01)04026704347995(17)250828(10)KMH20J0336, (01)04026704347995(17)250828(10)KMH20J0339, (01)04026704347995(17)250928(10)KMH20J0347, (01)04026704347995(17)250928(10)KMH20K0004, (01)04026704347995(17)250928(10)KMH20K0013, (01)04026704347995(17)250928(10)KMH20K0015, (01)04026704347995(17)250928(10)KMH20K0023, (01)04026704347995(17)250928(10)KMH20K0031, (01)04026704347995(17)250928(10)KMH20K0035, (01)04026704347995(17)250928(10)KMH20K0038, (01)04026704347995(17)250928(10)KMH20K0040, (01)04026704347995(17)250928(10)KMH20K0043, (01)04026704347995(17)250928(10)KMH20K0045, (01)04026704347995(17)250928(10)KMH20K0049, (01)04026704347995(17)250928(10)KMH20K0052, (01)04026704347995(17)250928(10)KMH20K0054, (01)04026704347995(17)250928(10)KMH20K0057, (01)04026704347995(17)250928(10)KMH20K0059, (01)04026704347995(17)250928(10)KMH20K0060, (01)04026704347995(17)250928(10)KMH20K0062, (01)04026704347995(17)250928(10)KMH20K0063, (01)04026704347995(17)250928(10)KMH20K0065, (01)04026704347995(17)250928(10)KMH20K0066, (01)04026704347995(17)250928(10)KMH20K0071, (01)04026704347995(17)250928(10)KMH20K0076, (01)04026704347995(17)250928(10)KMH20K0079, (01)04026704347995(17)250928(10)KMH20K0082, (01)04026704347995(17)250928(10)KMH20K0083, (01)04026704347995(17)250928(10)KMH20K0085, (01)04026704347995(17)250928(10)KMH20K0091, (01)04026704347995(17)250928(10)KMH20K0095, (01)04026704347995(17)250928(10)KMH20K0098, (01)04026704347995(17)250928(10)KMH20K0104, (01)04026704347995(17)250928(10)KMH20K0110, (01)04026704347995(17)250928(10)KMH20K0112, (01)04026704347995(17)250928(10)KMH20K0116, (01)04026704347995(17)250928(10)KMH20K0145, (01)04026704347995(17)250928(10)KMH20K0147, (01)04026704347995(17)250928(10)KMH20K0155, (01)04026704347995(17)250928(10)KMH20K0159, (01)04026704347995(17)250928(10)KMH20K0160, (01)04026704347995(17)250928(10)KMH20K0167, (01)04026704347995(17)250928(10)KMH20K0191, (01)04026704347995(17)250928(10)KMH20K0194, (01)04026704347995(17)250928(10)KMH20K0207, (01)04026704347995(17)250928(10)KMH20K0238, (01)04026704347995(17)250928(10)KMH20K0253, (01)04026704347995(17)250928(10)KMH20K0259, (01)04026704347995(17)250928(10)KMH20K0273, (01)04026704347995(17)250928(10)KMH20K0281, (01)04026704347995(17)250928(10)KMH20K0283, (01)04026704347995(17)250928(10)KMH20K0288, (01)04026704347995(17)250928(10)KMH20K0294, (01)04026704347995(17)250928(10)KMH20K0296, (01)04026704347995(17)250928(10)KMH20K0300, (01)04026704347995(17)250928(10)KMH20K0305, (01)04026704347995(17)250928(10)KMH20K0323, (01)04026704347995(17)250928(10)KMH20K0337, (01)04026704347995(17)250928(10)KMH20K0342, (01)04026704347995(17)250928(10)KMH20K0360, (01)04026704347995(17)250928(10)KMH20K0409, (01)04026704347995(17)250928(10)KMH20K0414, (01)04026704347995(17)250928(10)KMH20K0415, (01)04026704347995(17)250928(10)KMH20K0423, (01)04026704347995(17)250928(10)KMH20K0430, (01)04026704347995(17)250928(10)KMH20K0431, (01)04026704347995(17)250928(10)KMH20K0434, (01)04026704347995(17)250928(10)KMH20K0438, (01)04026704347995(17)251028(10)KMH20K0461, (01)04026704347995(17)251028(10)KMH20L0004, (01)04026704347995(17)251028(10)KMH20L0033, (01)04026704347995(17)251028(10)KMH20L0057, (01)04026704347995(17)251028(10)KMH20L0081, (01)04026704347995(17)251028(10)KMH20L0082, (01)04026704347995(17)251028(10)KMH20L0089, (01)04026704347995(17)251028(10)KMH20L0099, (01)04026704347995(17)251028(10)KMH20L0106, (01)04026704347995(17)251028(10)KMH20L0109, (01)04026704347995(17)251028(10)KMH20L0148, (01)04026704347995(17)251028(10)KMH20L0200, (01)04026704347995(17)251028(10)KMH20L0204, (01)04026704347995(17)251028(10)KMH20L0238, (01)04026704347995(17)251028(10)KMH20L0239, (01)04026704347995(17)251028(10)KMH20L0240, (01)04026704347995(17)251028(10)KMH20L0241, (01)04026704347995(17)251028(10)KMH20L0242, (01)04026704347995(17)251028(10)KMH20L0243, (01)04026704347995(17)251028(10)KMH20L0252, (01)04026704347995(17)251028(10)KMH20L0278, (01)04026704347995(17)251028(10)KMH20L0280, (01)04026704347995(17)251028(10)KMH20L0290, (01)04026704347995(17)251028(10)KMH20L0296, (01)04026704347995(17)251028(10)KMH20L0302, (01)04026704347995(17)251028(10)KMH20L0303, (01)04026704347995(17)251028(10)KMH20L0305, (01)04026704347995(17)251028(10)KMH20L0308, (01)04026704347995(17)251028(10)KMH20L0310, (01)04026704347995(17)251028(10)KMH20L0317, (01)04026704347995(17)251028(10)KMH20L0322, (01)04026704347995(17)251028(10)KMH20L0324, (01)04026704347995(17)251028(10)KMH20L0329, (01)04026704347995(17)251028(10)KMH20L0337, (01)04026704347995(17)251028(10)KMH20L0339, (01)04026704347995(17)251028(10)KMH20L0348, (01)04026704347995(17)251028(10)KMH20L0376, (01)04026704347995(17)251128(10)KMH20L0421, (01)04026704347995(17)251128(10)KMH20M0093, (01)04026704347995(17)251128(10)KMH20M0098, (01)04026704347995(17)251128(10)KMH20M0103, (01)04026704347995(17)251128(10)KMH20M0114, (01)04026704347995(17)251128(10)KMH20M0121, (01)04026704347995(17)251128(10)KMH20M0124, (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.
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
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- 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.