DeRoyal — Class II medical device recall Z-1642-2015
Terminated recall by DeRoyal Industries Inc, reported 2015-05-27, distributed nationwide. The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
| Recall number | Z-1642-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2015-04-17 |
| Classified | 2015-05-21 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2015-12-29 |
| Distributed | Nationwide (US) |
| Quantity | 5,359 units |
| Model numbers | 5500-000-003 |
Product
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
Reason for recall
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
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-1642-2015. 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.