FDA Device recall Z-1132-2022
Surgical Suture Kit
- FDA Device
- Class II
- ongoing
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Surgical Suture Kit by Stradis Healthcare, citing there is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1132-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-22 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | NC |
Product
Surgical Suture Kit
Reason
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Identifiers
| code_info | Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717 |
|---|
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-1132-2022%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.