FDA recall notice
Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices…
FDA Recall Confirmed · Manual Resuscitator · posted Jul 18, 2025
Key facts
| Notice | Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter |
|---|---|
| Device type | Manual Resuscitator |
| Status | Recall Confirmed |
| Posted | Jul 18, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- None Recall events referenced
- 1–9 UDI device identifiers named
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall notices and early alerts
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date: