Respironics SealFlex Single Port Ribbed Mask — Class I medical device recall Z-1058-2013
Terminated recall by Engineered Medical Systems,Inc, reported 2013-04-17, distributed in CA, CO, IN, NY, PA. The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicat
| Recall number | Z-1058-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Engineered Medical Systems,Inc, Indianapolis, IN, United States |
| Recall initiated | 2011-09-12 |
| Classified | 2013-04-10 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-08-02 |
| Distributed | CA, CO, IN, NY, PA |
| Reason classes | labeling |
| Lot numbers | 820550800110419 |
| Model numbers | 8-205508-00 |
Product
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Reason for recall
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
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-1058-2013. 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.