FDA Device recall Z-0490-2023
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray by Stradis Medical, citing medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0490-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Medical |
| Distribution | US |
Product
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Reason
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | UDI/DI (case) M75240714IES1, UDI/DI (kit)M75240714IES0, Serial/Lot Numbers: 22229490633, 22229490633, 22229490633 |
|---|
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 Stradis Medical
- HENRY SCHEIN, Amnio Tray, Item No.570-3059
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Vein, Item No.682-1732
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142
FDA Device · Class II · 2022-12-21 · Stradis Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2023%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.