FDA Device recall Z-1612-2025
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B by Medline Industries Northfield, citing there is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-03 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Reason
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Identifiers
| code_info | 1) DYNJ80807B, UDI-DI: 10195327415624(each), 40195327415625(case), Lot Number: 24IBH993 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2025%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.