TELEFLEX LLC: Medical Device Recall in 2022 - (Recall #: Z-0076-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Product Classification:

Class I

Date Initiated: August 29, 2022

Date Posted: October 26, 2022

Recall Number: Z-0076-2023

Event ID: 90816

Reason for Recall:

Incidents of device splitting or detaching during use

Status: Ongoing

Product Quantity: 42 units

Code Information:

a) 19012, UDI: (01)04026704400423(17)250528(10)KMZ21A0099; b) 19012T, UDI: (01)04026704400423(17)250628(10)202025, (01)04026704400423(17)250628(10)202027, (01)04026704400423(17)250828(10)202028, (01)04026704400423(17)250828(10)KMZ20J0079, (01)04026704400423(17)251228(10)KMZ20J0861, (01)04026704400423(17)251228(10)KMZ21A0100, (01)04026704400423(17)251228(10)KMZ21A0127, (01)04026704400423(17)251228(10)KMZ21A0238, (01)04026704400423(17)251228(10)KMZ21A0425, (01)04026704400423(17)251228(10)KMZ21A0427, (01)04026704400423(17)251228(10)KMZ21A0522, (01)04026704400423(17)251228(10)KMZ21A0535, (01)04026704400423(17)251228(10)KMZ21A0617, (01)04026704400423(17)251228(10)KMZ21A0712, (01)04026704400423(17)251228(10)KMZ21A0828, (01)04026704400423(17)251228(10)KMZ21A0854, (01)04026704400423(17)251228(10)KMZ21A0860, (01)04026704400423(17)251228(10)KMZ21A0909, (01)04026704400423(17)260128(10)KMZ21A0926, (01)04026704400423(17)260628(10)KMZ21B0141, (01)04026704400423(17)260628(10)KMZ21G0174, (01)04026704400423(17)260628(10)KMZ21G0180, (01)04026704400423(17)260628(10)KMZ21G0181, (01)04026704400423(17)260728(10)KMZ21G1067, (01)04026704400423(17)260828(10)KMZ21H0277, (01)04026704400423(17)260828(10)KMZ21J0069, (01)04026704400423(17)260928(10)KMZ21J0386, (01)04026704400423(17)260928(10)KMZ21K0208, (01)04026704400423(17)260928(10)KMZ21K0648, (01)04026704400423(17)260928(10)KMZ21K0707, (01)04026704400423(17)261028(10)KMZ21K0856, (01)04026704400423(17)261128(10)KMZ21L0309, (01)04026704400423(17)261128(10)KMZ21M0061, (01)04026704400423(17)261128(10)KMZ21M0492, (01)04026704400423(17)261128(10)KMZ21M0493, (01)04026704400423(17)270128(10)KMZ21M0813, (01)04026704400423(17)270128(10)KMZ22B0105, (01)04026704400423(17)270128(10)KMZ22B0117, (01)04026704400423(17)270128(10)KMZ22B0118, (01)04026704400423(17)270228(10)KMZ22B0508, (01)04026704347995(17)241128(10)KMZ22C0622.

Distribution Pattern:

US nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated