8Fr SAFE GRAD CAT W/Valve — Class II medical device recall Z-0656-2019
Terminated recall by COVIDIEN LLC, reported 2018-12-26, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. The product was released into commercial distribution while subject to importation refusal.
| Recall number | Z-0656-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-11-05 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-08-14 |
| Distributed | AL, 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 |
| Quantity | 32,071 units |
| Lot numbers | 1816211264 |
| Model numbers | 36826 |
Product
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Reason for recall
The product was released into commercial distribution while subject to importation refusal.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0656-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.