FDA Device recall Z-0126-2022
Tenaculum, Plastic
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Tenaculum, Plastic by Stradis Medical, citing firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0126-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-10 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Medical |
| Distribution | US |
Product
Tenaculum, Plastic
Reason
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Identifiers
| code_info | Part Number: 356T |
|---|
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-0126-2022%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.