MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF
Reason for recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- REF
- DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS)
- Lot #
19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086 — +14 moreShow all
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 #
- 19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208; 3)
- REF
- DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS)
- Lot #
21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124 — +19 moreShow all
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 #
- 19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002; 5)
- REF
- DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS)
- Lot #
- 19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049; 6)
- REF
- DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS)
- Lot #
- 22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071; 7)
- REF
- DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS)
- Lot #
- 19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876; 8)
- REF
- DYNJ905365A, UDI/DI 10193489759037 (EA) 40193489759038 (CS)
- Lot #
- 19IBR377, 20CBO773, 20GBI734, 20GBJ843, 20HBC012, 20IBQ906, 20JBO730, 21CBZ725, 21DBU031, 21GBF999, 21IBC232, 21VBB589; 9)
- REF
- DYNJ906474, UDI/DI 10193489750492 (EA) 40193489750493 (CS)
- Lot #
- 20ADB316, 20BDC489; 10)
- REF
- DYNJ906474A, UDI/DI 10193489344721 (EA) 40193489344722 (CS)
- Lot #
- 20EDC407, 20FDB425, 20HDA265, 20KDA931, 20KDC466, 21BDA054, 21EDA134, 21FDB465, 21GDB063, 21HDB526, 21IDA248; 11)
- REF
- DYNJ907802, UDI/DI 10193489890006 (EA) 40193489890007 (CS)
- Lot #
- 21GBI826, 22IBH914; 12)
- REF
- DYNJ907863, UDI/DI 10193489913187 (EA) 40193489913188 (CS)
- Lot #
- 21GBJ056, 21JBZ373, 21KBX700, 21LBV116; 13)
- REF
- DYNJ908264, UDI/DI 10195327020118 (EA) 40195327020119 (CS)
- Lot #
- 21LBU103
Show 16 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0786-2025
- FDA device classification · FTNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.3925The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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