MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5 — Class II medical device recall Z-2151-2018
Terminated recall by Sun Med, LLC, reported 2018-06-20, distributed in IL, OH. There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach
| Recall number | Z-2151-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Med, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2018-05-24 |
| Classified | 2018-06-09 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-05-12 |
| Distributed | IL, OH |
| Quantity | 55 cases |
| Reason classes | device malfunction |
| Lot numbers | 313049, 313326, 313436 |
| Model numbers | CPRM1116PD5 |
Product
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
Reason for recall
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
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-2151-2018. 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.