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 | 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. |
| Product | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 |
| Quantity | 157 packs |
| Distribution | US Nationwide distribution in the states of IL, MO. |
| Initiated | 2022-12-12 |
| Classified | 2023-01-09 |
| Terminated | 2026-05-29 |
| Recall number | Z-0927-2023 |
| 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-0927-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91331/
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