FDA Device recall Z-1462-2025
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1462-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Identifiers
| code_info | 1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case), Lot Number 21BBH575A; 2) Pack Number…1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case), Lot Number 21BBH575A; 2) Pack Number DYNJ63577C: UDI/DI 10193489267143 (each) 40193489267144 (case), Lot Number 21BBI089A; 3) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A; 4) Pack Number DYNJ60669G: UDI/DI 10889942794942 (each) 40889942794943 (case), Lot Number 21EME131A; 5) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A; 6) Pack Number DYNJ40647G: UDI/DI 10193489270976 (each) 40193489270977 (case), Lot Number 21IMH836A; 7) Pack Number DYNJ0665560D: UDI/DI 10195327089795 (each) 40195327089796 (case), Lot Number 22CMB464A; 8) Pack Number DYNJ40356A: UDI/DI 10193489228335 (each) 40193489228336 (case), Lot Number 22JBF484Z; 9) Pack Number DYNJ0252232U: UDI/DI 10195327217334 (each) 40195327217335 (case), Lot Number 22JBG465Z; 10) Pack Number DYNJ60232A: UDI/DI 10195327222451 (each) 401953272 |
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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-1462-2025%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.