FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: 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
- Recall number
- Z-1462-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Status
- Open, Classified
- Initiated
- 2025-02-11
- Posted
- 2025-03-26
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
- Quantity
- 1228 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- 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) 40195327222452 (case), Lot Number 22JBN921Z; 11) Pack Number DYNJ43576A: UDI/DI 10193489920116 (each) 40193489920117 (case), Lot Number 22JBU153Z; 12) Pack Number DYNJ00264L: UDI/DI 10193489801866 (each) 40193489801867 (case), Lot Number 22JBU265A; 13) Pack Number DYNJ49742B: UDI/DI 10195327210267 (each) 40195327210268 (case), Lot Number 22JBV346A; 14) Pack Number DYNJ14039B: UDI/DI 10193489324495 (each) 40193489324496 (case), Lot Number 22JBW642A; 15) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (case), Lot Number 22JBY434A; 16) Pack Number DYNJ45861B: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC920Z; 17) Pack Number DYNJ68288A: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC927Z
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28