FDA Device recall Z-1690-2023
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack by Cardinal Health 200, citing inadvertently released for distibution without sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1690-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | GA |
Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reason
Inadvertently released for distibution without sterility assurance.
Identifiers
| code_info | Catalog Number: SMA21LPUHJ; Lot Number: 019693 |
|---|
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-1690-2023%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.