FDA Device recall Z-2087-2023
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
- 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) STURDI STRAINER TRAY STANDARD, REF '89-5014 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-2087-2023 |
| 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) STURDI STRAINER TRAY STANDARD, REF '89-5014
Reason
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Identifiers
| code_info | a) REF '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit), , Lot Numbers: 58770294 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Deroyal Industries
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
FDA Device · Class II · 2026-09-30 · Deroyal Industries - DeRoyal Industries Inc
FDA Device · Class II · 2026-06-10 · Deroyal Industries - DeRoyal REF 71-C5100NS Tubing, Suction, Connector
FDA Device · Class II · 2025-03-12 · Deroyal Industries - DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Device · Class II · 2025-02-26 · Deroyal Industries - DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
FDA Device · Class II · 2024-11-13 · Deroyal Industries
All Deroyal Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2087-2023%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.