Class I — Engineered Medical Systems,Inc
| Recalling firm | Engineered Medical Systems, LLC |
|---|---|
| Registered facility | Engineered Medical Systems, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
| 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. . |
| Quantity | 1500pcs, 75cs {20pcs per cases) |
| Distribution | Distributed in the states of PA, IN, NY, CO, and CA. |
| Initiated | 2011-09-12 |
| Classified | 2013-04-10 |
| Terminated | 2013-08-02 |
| Recall number | Z-1058-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Engineered Medical Systems,Inc (Z-1058-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64751/
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