DeRoyal CANNULTED HIP PACK CSM — Class II medical device recall Z-0581-2023
Ongoing recall by DeRoyal Industries Inc, reported 2022-12-21, distributed in AL, AZ, CT, FL, GA, IL, IN, KS…. DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
| Recall number | Z-0581-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2022-11-03 |
| Classified | 2022-12-15 |
| Reported by FDA | 2022-12-21 |
| Distributed | AL, AZ, CT, FL, GA, IL, IN, KS, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, PA, TN, TX, VA, WI |
| Quantity | 108 kits |
| Lot numbers | 56183862, 56613244 |
| Model numbers | 89-6977.09 |
| Expiration dates | 2025-03-01, 2025-09-01 |
Product
DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
Reason for recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
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-0581-2023. 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.