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Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A...

FDA Device Recall #Z-2986-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-2986-2024
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

Product Description

Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A

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

DYNDM1076A . Lot Number 19CBP748 ; DYNDM1076A . Lot Number 19DBH317 ; DYNDM1076A . Lot Number 19FBT944 ; DYNJ45158A . Lot Number 21KBK059 ; DYNJ45158A . Lot Number 21LBB289 ; DYNJ45158A . Lot Number 19ABZ159 ; DYNJ45158A . Lot Number 22DBS953 ; DYNJ45158A . Lot Number 22GBC899 ; DYNJ45158A . Lot Number 22GBE801 ; DYNJ45158A . Lot Number 19FBG969 ; DYNJ45158A . Lot Number 19FBM779 ; DYNJ45158A . Lot Number 19GBS210 ; DYNJ45158A . Lot Number 19HBS882 ; DYNJ45158A . Lot Number 19IBN282 ; DYNJ45158A . Lot Number 19JBB002 ; DYNJ45158A . Lot Number 23ABR333 ; DYNJ45158A . Lot Number 23CBK931 ; DYNJ45158A . Lot Number 23HBJ279 ; DYNJ45158A . Lot Number 23IBF733 ; DYNJ45158A . Lot Number 20HBR669 ; DYNJ45158A . Lot Number 20HBX586 ; DYNJ45158A . Lot Number 20LBZ104 ; DYNJ45158A . Lot Number 21EBP316 ; DYNJ51939. Lot Number 22CBA086 ; DYNJ51939. Lot Number 19ABY439 ; DYNJ51939. Lot Number 22OBI663 ; DYNJ51939. Lot Number 19HBH583 ; DYNJ51939. Lot Number 19IBU567 ; DYNJ51939. Lot Number 19JBW741 ; DYNJ51939. Lot Number 19JBX646 ; DYNJ51939. Lot Number 20FBT320 ; DYNJ51939. Lot Number 20LBF765 ; DYNJ51939. Lot Number 20LBK574 ; DYNJ56573. Lot Number 19ABN855 ; DYNJ56573. Lot Number 19CBF516 ; DYNJ56573. Lot Number 19EBQ417 ; DYNJ56573. Lot Number 19HBP237 ; DYNJ56573. Lot Number 19UBC593 ; DYNJ56573. Lot Number 19VBA937 ; DYNJ56573. Lot Number 19KBB135 ; DYNJ58876A . Lot Number 20HBW903 ; DYNJ58876A . Lot Number 20IBJ399 ; DYNJ58876A . Lot Number 20IBM299

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

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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.

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