Non-Rebreather Oxygen Mask — Class II medical device recall Z-2243-2017
Terminated recall by ConvaTec, Inc, reported 2017-06-14, distributed in CA, CT, FL, GA, IL, MO, NC, NJ….
| Recall number | Z-2243-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2017-05-10 |
| Classified | 2017-06-02 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2021-08-27 |
| Distributed | CA, CT, FL, GA, IL, MO, NC, NJ, NY, OH, PA, PR, RI, VA |
| Countries outside the US | AU, BE, CA, CH, CZ, DE, DK, FI, FR, GB, GR, IL, IT, JO, JP, MT, MY, NL, NO, SA, SE, VN |
| Lot numbers | 100050, 100196, 100574, 100581, 102698, 103003, 104062, 104331, 104424, 104928, 105597 |
Product
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Reason for recall
Not stated by FDA.
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-2243-2017. 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.