FDA Device recall Z-2089-2023
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 by Deroyal Industries, citing the outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2089-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-30 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Reason
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Identifiers
| code_info | a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114 |
|---|
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-2089-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.