RecallRadar

FDA Device recall Z-0152-2022

smiths medical portex Loss of Resistance Device, REF 100/398/000

On 2021-10-27 the FDA classified a Class II recall of smiths medical portex Loss of Resistance Device, REF 100/398/000 by Smiths Medical Asd, citing the labeling was missing information on sterilization and prohibition of reuse.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0152-2022
ClassificationClass II
Statusterminated
Initiated2020-12-08
Published2021-10-27
Last updated2026-09-13 11:56 UTC
CompanySmiths Medical Asd
Distributionn/a

Product

smiths medical portex Loss of Resistance Device, REF 100/398/000

Reason

The labeling was missing information on sterilization and prohibition of reuse.

Identifiers

code_infoLot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0152-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.