FDA Device recall Z-0158-2025
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L
- 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) CONE BIOPSY PACK, REF DYNJ17534L 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-0158-2025 |
| 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) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129
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 DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI…a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers: 23LBI584; c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers: 23LBP833; d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers: 23LBN740; e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers: 23LBP401; f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers: 23KBD517; g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers: 23LBR787; h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers: 24ABA444; i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers: 23LBL347; j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers: 24ABA492; k) REF DYNJ68393A, UDI/DI 4019 |
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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-0158-2025%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.