FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CUSTOM PACK A, REF DYNJ82735; 7) NSR-SMR, REF DYNJ903144C; 8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A; 9) SEPTOPLASTY, REF DYNJ906474; 10) SEPTOPLASTY, REF DYNJ906474A; 11) FREE FLAP, REF DYNJ907802; 12) MINOR DIEP, REF DYNJ907863; 13) MAIN FLAP, REF DYNJ908264.
- Recall number
- Z-0786-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CUSTOM PACK A, REF DYNJ82735; 7) NSR-SMR, REF DYNJ903144C; 8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A; 9) SEPTOPLASTY, REF DYNJ906474; 10) SEPTOPLASTY, REF DYNJ906474A; 11) FREE FLAP, REF DYNJ907802; 12) MINOR DIEP, REF DYNJ907863; 13) MAIN FLAP, REF DYNJ908264.
- Status
- Open, Classified
- Initiated
- 2024-11-21
- Posted
- 2024-12-30
- Terminated
- not on file
- Reason
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Root cause
- Nonconforming Material/Component
- Action
- Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
- Quantity
- 3903 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Lot, serial or model codes
- 1) REF DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Numbers: 19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086, 20AKB057, 20BKB114, 20FKB215, 20JKA546, 20LMA968, 20LMF795, 21DMA309, 21DMF310, 21FMA264, 21GMB043, 21HMD757, 21JMC608, 21KMH631, 22CMB438; 2) REF DYNJ42833A, UDI/DI 10888277503991 (EA) 40888277503992 (CS), Lot Numbers: 19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208; 3) REF DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS), Lot Numbers: 21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124, 22GBD852, 22HBF050, 22HBJ420, 22IBJ529, 22KBR876, 23BBA545, 23CBD715, 23CBQ582, 23DBH453, 23HBE012, 23HBR165, 23IBK906, 23KBP817, 24BBA648, 24DBD590, 24FBI859, 24GBU033, 24IBG868, 24JBI576; 4) REF DYNJ50692C, UDI/DI 10193489752199 (EA) 40193489752190 (CS), Lot Numbers: 19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002; 5) REF DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS), Lot Numbers: 19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049; 6) REF DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS), Lot Numbers: 22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071; 7) REF DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS), Lot Numbers: 19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876; 8) REF DYNJ905365A, UDI/DI 10193489759037 (EA) 40193489759038 (CS), Lot Numbers: 19IBR377, 20CBO773, 20GBI734, 20GBJ843, 20HBC012, 20IBQ906, 20JBO730, 21CBZ725, 21DBU031, 21GBF999, 21IBC232, 21VBB589; 9) REF DYNJ906474, UDI/DI 10193489750492 (EA) 40193489750493 (CS), Lot Numbers: 20ADB316, 20BDC489; 10) REF DYNJ906474A, UDI/DI 10193489344721 (EA) 40193489344722 (CS), Lot Numbers: 20EDC407, 20FDB425, 20HDA265, 20KDA931, 20KDC466, 21BDA054, 21EDA134, 21FDB465, 21GDB063, 21HDB526, 21IDA248; 11) REF DYNJ907802, UDI/DI 10193489890006 (EA) 40193489890007 (CS), Lot Numbers: 21GBI826, 22IBH914; 12) REF DYNJ907863, UDI/DI 10193489913187 (EA) 40193489913188 (CS), Lot Numbers: 21GBJ056, 21JBZ373, 21KBX700, 21LBV116; 13) REF DYNJ908264, UDI/DI 10195327020118 (EA) 40195327020119 (CS), Lot Numbers: 21LBU103.
- 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