Ventlab — Class II medical device recall Z-0365-2024
Ongoing recall by SunMed Holdings, LLC, reported 2023-11-29, distributed nationwide. A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
| Recall number | Z-0365-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SunMed Holdings, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2023-10-11 |
| Classified | 2023-11-21 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10889483086902, 10889483086919, 10889483086926, 10889483092590, 10889483102954, 10889483103111, 10889483103128, 10889483103777, 10889483103784, 10889483104330, 10889483104354, 10889483104545, 10889483104903, 10889483105771, 10889483107324, 10889483107331, 10889483107904, 10889483111734, 10889483158913, 10889483160497, 10889483172322, 10889483231142, 30889483086906, 30889483086913, 30889483086920 and 20 more |
| Model numbers | PRO-1927, PWS10, SS3200MB, SS3200MB-2, SS3200MB-D1, SS3200MB-I, SS3200MB-MMC, SS3200MB-PW, SS3200MBF, SS3200MBF-2, SS3200MBP, SS3200MBP-2, SS3200MBP-2I, SS3200MBP-M00, SS3200MC, SS3200MC-P2, SS3200OB, SS3200OBP, SS3200OBPC-T, SS3204MB, SS3204MB-D12, SS3204MBF-2, SS3204MC-P2, SS3206MCP-S1 |
| Expiration dates | 2028-10-11 |
Product
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflation Bag Reservoir, Manometer, PEEP Valve, and 40cm Pop-Off REF # PRO-1927.
Reason for recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
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-0365-2024. 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.