Class II — DeRoyal Industries Inc
| Recalling firm | DEROYAL INDUSTRIES, INC. |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. |
| Product | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital |
| Quantity | 13,900 units |
| Distribution | Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY |
| Initiated | 2014-08-22 |
| Classified | 2014-10-20 |
| Terminated | 2015-04-15 |
| Recall number | Z-0097-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DeRoyal Industries Inc (Z-0097-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69319/
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