FDA Device recall Z-1058-2013
Respironics SealFlex Single Port Ribbed Mask (Infant)
- FDA Device
- Class I
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class I recall of Respironics SealFlex Single Port Ribbed Mask (Infant) by Engineered Medical Systems, citing the mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1058-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2011-09-12 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Engineered Medical Systems |
| Distribution | CA, CO, IN, NY, PA |
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
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Identifiers
| code_info | REF 8-205508-00 Lot Number: 820550800110419. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1058-2013%22
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