Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAS...
FDA Device Recall #Z-2423-2026 - Class II, April 27, 2026
Recall Summary
| Recall Number | Z-2423-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 27, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 49,654 kits total |
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
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 Pattern
US Nationwide distribution. OUS distribution pending.
Lot / Code Information
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 from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2790-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2788-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2791-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2789-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bo... | Jun 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.