DeRoyal — Class II medical device recall Z-0098-2015
Terminated recall by DeRoyal Industries Inc, reported 2014-10-29, distributed nationwide. These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition
| Recall number | Z-0098-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2014-08-22 |
| Classified | 2014-10-20 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 5,112 units |
| Reason classes | packaging |
| Lot numbers | 364817213 |
| Model numbers | 71-6518 |
Product
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Reason for recall
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
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-0098-2015. 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.