DeRoyal Pacemaker Tray Pgybk — Class I medical device recall Z-1832-2021
Terminated recall by DeRoyal Industries Inc, reported 2021-06-16, distributed nationwide. DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which
| Recall number | Z-1832-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2021-05-14 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 12 trays |
| Reason classes | labeling |
| Lot numbers | 54239375 |
| Model numbers | 89-6360.06 |
| Expiration dates | 2022-02-01 |
Product
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Reason for recall
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
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-1832-2021. 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.