DeRoyal ORGAN RECOVERY PACK PGYBK — Class II medical device recall Z-0927-2023
Terminated recall by DeRoyal Industries Inc, reported 2023-01-18, distributed nationwide. DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable
| Recall number | Z-0927-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2022-12-12 |
| Classified | 2023-01-09 |
| Reported by FDA | 2023-01-18 |
| Terminated | 2026-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 157 packages |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00749756903936 |
| Lot numbers | 57391129, 57755421, 57900931, 57913767 |
| Model numbers | 89-9004.09, 89-9004.10 |
| Expiration dates | 2023-05-01 |
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Reason for recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
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-0927-2023. 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.