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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2023%22
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