FDA Device recall Z-0165-2025
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A
- 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) PLASTIC PACK, REF DYNJ42735A 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-0165-2025 |
| 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) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTOM PLASTIC PACK, REF DYNJ68062; m) PLASTIC LIMB SJHC-LF, REF DYNJ84997
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) DYNJ42735A, UDI/DI 40888277226433 (each), 10888277226432 (case), Lot Numbers: 23LBP975; b) DYNJ43457, UDI/DI 40888…a) DYNJ42735A, UDI/DI 40888277226433 (each), 10888277226432 (case), Lot Numbers: 23LBP975; b) DYNJ43457, UDI/DI 40888277055309 (each), 10888277055308 (case), Lot Numbers: 23LBS052; c) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 24ABF270; d) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 23LBO013; e) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 24ABC805; f) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 23LBN742; g) DYNJ57895, UDI/DI 40889942790372 (each), 10889942790371 (case), Lot Numbers: 23KBF265; h) DYNJ62803, UDI/DI 40193489688994 (each), 10193489688993 (case), Lot Numbers: 23LBN303; i) DYNJ64376, UDI/DI 40193489807845 (each), 10193489807844 (case), Lot Numbers: 24ABD094; j) DYNJ66619A, UDI/DI 40195327427840 (each), 10195327427849 (case), Lot Numbers: 23LBU414; k) DYNJ68030, UDI/DI 40193489469289 (each), 10193489469288 (case), Lot Num |
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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-0165-2025%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.