← FDA ENFORCEMENT
Z-2423-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-06-24
Distribution
US Nationwide distribution. OUS distribution pending.
Firm state
IL
Product quantity
49,654 kits total
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Product description

Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M PLASTIC PACK DYNJ84766 PLASTIC PACK-LF DYNJ0578842M PLASTICS EXTREMITY PACK DYNJ63803C PLASTICS PK - NO SYR DYNJ62433D RR-ASC-RHINOPLASTY PACK-LF DYNJ81772C TRANSGENDER PACK DYNJT7588 WH PLASTIC MAJOR PACK DYNJ89048A

Code / lot info

DYNJT5893 UDI-DI 10198459517839 Lot 25KBA123 SYNJ10306A UDI-DI 10193489296891 Lots 25LBO305 26CBD081 DYNJ68023 UDI-DI 10193489468083 Lot 25KBI169 DYNJ909926C UDI-DI 10198459423109 Lots 25LBC067 25LBR659 DYNJ84081B UDI-DI 10198459462474 Lot 25LMI881 DYNJ905362C UDI-DI 10198459346842 Lots 25KBN239 25LBF694 DYNJ0660040R UDI-DI 10889942220083 Lots 25JME572 26AMA936 DYNJ89023A UDI-DI 10198459388316 Lot 25KBC500 DYNJ902510M UDI-DI 10198459683374 Lots 26CBM279 26CBO942 DYNJ84766 UDI-DI 10195327414108 Lot 26BBC049 DYNJ0578842M UDI-DI 10193489288292 Lot 25LMG027 DYNJ63803C UDI-DI 10198459149825 Lots 25LBN476 26CBC156 DYNJ62433D UDI-DI 10198459498176 Lots 25KBC752 25KBM917 DYNJ81772C UDI-DI 10198459349362 Lots 25LMH594 25LMI396 DYNJT7588 UDI-DI 10198459635182 Lot 26AMA250 DYNJ89048A UDI-DI 10198459388477 Lot 26BBD124

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.