RecallRadar

FDA Device recall Z-0656-2019

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

On 2018-12-26 the FDA classified a Class II recall of 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826 by Covidien, citing the product was released into commercial distribution while subject to importation refusal.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0656-2019
ClassificationClass II
Statusterminated
Initiated2018-11-05
Published2018-12-26
Last updated2026-09-13 11:54 UTC
CompanyCovidien
DistributionAL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI

Product

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Reason

The product was released into commercial distribution while subject to importation refusal.

Identifiers

code_infoLot Number 1816211264

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0656-2019%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.