FDA Device recall Z-1396-2022
YelloPort Elite Universal Seal
- FDA Device
- Class II
- completed
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of YelloPort Elite Universal Seal by Surgical Innovations, citing there is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1396-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-06-02 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Surgical Innovations |
| Distribution | US |
Product
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Reason
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Identifiers
| code_info | All Lots; UDI/DI:05051986001562 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2022%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.