FDA Device recall Z-0175-2025
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C by Medline Industries Northfield, citing it has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0175-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Reason
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Identifiers
| code_info | a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI…a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers: 23LBN531; c) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers: 23LBL712; d) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers: 24ABR224 |
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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-0175-2025%22
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