DeRoyal SafeLiner Suction Canister — Class II medical device recall Z-1283-2023
Ongoing recall by DeRoyal Industries Inc, reported 2023-03-29, distributed nationwide. The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not
| Recall number | Z-1283-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2023-02-09 |
| Classified | 2023-03-23 |
| Reported by FDA | 2023-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 27,200 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 50749756377046 |
| Lot numbers | 58447585 |
| Model numbers | PHESL-1000B |
| Expiration dates | 2027-12-22 |
Product
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Reason for recall
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
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-1283-2023. 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.