DeRoyal — Class II medical device recall Z-2679-2016
Terminated recall by DeRoyal Industries Inc, reported 2016-09-07, distributed in LA, TN. The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Res
| Recall number | Z-2679-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2016-08-11 |
| Classified | 2016-08-26 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-06-13 |
| Distributed | LA, TN |
| Quantity | 24 units |
| Reason classes | sterility |
| Lot numbers | 40004006 |
| Model numbers | 89-3076.08 |
Product
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Reason for recall
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
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-2679-2016. 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.