FDA Device recall Z-0862-2022
Surgicare Neuro Pack - Neurological Kit
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Surgicare Neuro Pack - Neurological Kit by Stradis Medical, citing the outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0862-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-25 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Medical |
| Distribution | US |
Product
Surgicare Neuro Pack - Neurological Kit
Reason
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 2034346714…SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545 |
|---|
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-0862-2022%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.