Adult Manual Resuscitator with Medium Adult Mask — Class I medical device recall Z-1814-2025
Ongoing recall by SunMed Holdings, LLC, reported 2025-06-11, distributed nationwide. Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead o
| Recall number | Z-1814-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SunMed Holdings, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2025-05-01 |
| Classified | 2025-05-30 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 11,358 |
| UPC / GTIN / UDI-DI | 10884389164822, 40884389164823 |
| Lot numbers | 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 526807, 526808, 526809, 526810, 526811, 526814, 526815, 526816, 526817, 526818 |
| Model numbers | CPRM1116F |
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Reason for recall
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.
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-1814-2025. 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.