Oxygen Masks — Class II medical device recall Z-2228-2017
Terminated recall by ConvaTec, Inc, reported 2017-06-14, distributed in CA, CT, FL, GA, IL, MO, NC, NJ…. Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by di
| Recall number | Z-2228-2017 |
|---|---|
| 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 |
| Quantity | 816,709 |
| Reason classes | device malfunction |
| Lot numbers | 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530 |
Product
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Reason for recall
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
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-2228-2017. 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.