FDA Device recall Z-0073-2023
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only
- FDA Device
- Class I
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class I recall of Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only by Teleflex, citing incidents of device splitting or detaching during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0073-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-08-29 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Reason
Incidents of device splitting or detaching during use
Identifiers
| code_info | a) 19261, UDI: (01)04026704388486(17)260128(10)KMH21B0193, (01)04026704388486(17)251028(10)KMH20L0234, (01)04026704388…a) 19261, UDI: (01)04026704388486(17)260128(10)KMH21B0193, (01)04026704388486(17)251028(10)KMH20L0234, (01)04026704388486(17)260828(10)KMH21J0246, (01)04026704388486(17)261028(10)KMH21L0294, (01)04026704388486(17)261228(10)KMH22A0230; b) 19272, UDI: (01)04026704388509(17)260428(10)KMZ21E0613, (01)04026704388509(17)260528(10)KMZ21F0939 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0073-2023%22
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