Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack nu...
FDA Device Recall #Z-2623-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2623-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1,679,067 units in total |
Product Description
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
DYNJ34129C , Lot Number 21GBT130 , DYNJ34129C , Lot Number 21LBL623 , DYNJ34129C , Lot Number 22ABM033 , DYNJ34129C , Lot Number 22ABX499 , DYNJ34129C , Lot Number 19BBD954 , DYNJ34129C , Lot Number 19DBZ455 , DYNJ34129C , Lot Number 19EBU077 , DYNJ34129C , Lot Number 19GBU537 , DYNJ34129C , Lot Number 22IBG550 , DYNJ34129C , Lot Number 19JBN034 , DYNJ34129C , Lot Number 20BBF056 , DYNJ34129C , Lot Number 23FBG792 , DYNJ34129C , Lot Number 23GBE376 , DYNJ34129C , Lot Number 20FBS002 , DYNJ34129C , Lot Number 23JBR570 , DYNJ34129C , Lot Number 23JBY629 , DYNJ34129C , Lot Number 23KBU960 , DYNJ34129C , Lot Number 23KBW607 , DYNJ34129C , Lot Number 20KBW597 , DYNJ34129C , Lot Number 20LBM567 , DYNJ34129C , Lot Number 21EBA688 , DYNJ54607A , Lot Number 21HBS933 , DYNJ54607A , Lot Number 21JBH960 , DYNJ54607A , Lot Number 21JBZ002 , DYNJ54607A , Lot Number 21LBJ925 , DYNJ54607A , Lot Number 19BBP092 , DYNJ54607A , Lot Number 19CBB568 , DYNJ54607A , Lot Number 22GBH746 , DYNJ54607A , Lot Number 22GBZ352 , DYNJ54607A , Lot Number 19GBT320 , DYNJ54607A , Lot Number 22IBG226 , DYNJ54607A , Lot Number 19VBA464 , DYNJ54607A , Lot Number 19LBN255 , DYNJ54607A , Lot Number 23EBA098 , DYNJ54607A , Lot Number 20DBI269 , DYNJ54607A , Lot Number 20GBW370 , DYNJ54607A , Lot Number 21ABE502 , DYNJ54607A , Lot Number 21ABO952 , DYNJ54607A , Lot Number 21ABT074 , DYNJ61839B , Lot Number 21JBP698 , DYNJ61839B , Lot Number 21LBL729 , DYNJ61839B , Lot Number 22ABU420 , DYNJ61839B , Lot Number 22EBJ226 , DYNJ61839B , Lot Number 22HBA748 , DYNJ61839B , Lot Number 22IBR542 , DYNJ61839B , Lot Number 19IBN952 , DYNJ61839B , Lot Number 19LBT615 , DYNJ61839B , Lot Number 23EBD346 , DYNJ61839B , Lot Number 23GBE331 , DYNJ61839B , Lot Number 20DBD020 , DYNJ61839B , Lot Number 20GBV525 , DYNJ61839B , Lot Number 20JBC796 , DYNJ61839B , Lot Number 24ABV143 , DYNJ61839B , Lot Number 20KBZ290 , DYNJ61839B , Lot Number 21DBR237 , DYNJ61839B , Lot Number 21EBP718
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
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.