RecallRadar

FDA Device recall Z-2520-2021

10 ga ARS Decompression Needle, Part Number ZZ-0298

On 2021-09-29 the FDA classified a Class II recall of 10 ga ARS Decompression Needle, Part Number ZZ-0298 by North American Rescue, citing the device includes the incorrect Instructions for Use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2520-2021
ClassificationClass II
Statusterminated
Initiated2021-08-27
Published2021-09-29
Last updated2026-09-13 11:56 UTC
CompanyNorth American Rescue
DistributionPR

Product

10 ga ARS Decompression Needle, Part Number ZZ-0298

Reason

The device includes the incorrect Instructions for Use.

Identifiers

code_infoPart Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ

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-2520-2021%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.