FDA Device recall Z-0561-2023
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 by Deroyal Industries, citing deRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-03 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | AL, AZ, CT, FL, GA, IL, IN, KS, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, PA, TN, TX, VA, WI |
Product
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Reason
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Identifiers
| code_info | Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/202…Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2023%22
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