MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.

Recall number

Z-0783-2025

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.

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

943 units

Distribution

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Lot, serial or model codes

1) REF DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers: 19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327; 2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers: 23JBK732; 3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers: 23HBD879; 4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers: 19BBA689, 19CBD918; 5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers: 21EMF317; 6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers: 22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141; 7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers: 19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245; 8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers: 19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477; 9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers: 21EBC333; 10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers: 22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH076, 23LBG978; 11) REF DYNJ910072, UDI/DI 10195327567538 (EA) 40195327567539 (CS), Lot Numbers: 24CBL710; 12) REF DYNJ910120A, UDI/DI 10195327689872 (EA) 40195327689873 (CS), Lot Numbers: 24HMK254.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FDE

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

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

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