Class I — SunMed Holdings, LLC
| Recalling firm | SunMed Group Holdings, LLC dba AirLife |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death. |
| Product | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F |
| Quantity | 11,358 |
| Distribution | US Nationwide distribution via Medline. |
| Initiated | 2025-05-01 |
| Classified | 2025-05-30 |
| Recall number | Z-1814-2025 |
| 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 — SunMed Holdings, LLC (Z-1814-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96801/
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