Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DY
Summary
The FDA issued a Class II for Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ103 by Medline Industries, LP. Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable fo.
Details
Source
Device Recall
External ID
Z-2423-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
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
Lot/Code 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
Quantity Affected: 49,654 kits total
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.
Distribution
US Nationwide distribution. OUS distribution pending.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-27
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2423-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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