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Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2...

FDA Device Recall #Z-3059-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-3059-2024
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) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

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

BP115, Lot Number 21BBG338 ; BP115, Lot Number 21CBE353 ; BP115, Lot Number 21CBJ050 ; DYLAB1044, Lot Number 23GBM782 ; DYNDA1431A, Lot Number 2020012890; DYNDA1683A, Lot Number 2019011790; DYNDA1683A, Lot Number 2019032590; DYNDA1683A, Lot Number 2019042390; DYNDA1683A, Lot Number 2019072390; DYNDA1683A, Lot Number 2019090990; DYNDA1683A, Lot Number 2019102390; DYNDA1683A, Lot Number 2019112290; DYNDA1683A, Lot Number 2020030990; DYNDH1641A , Lot Number 21JBE248 ; DYNDH1641A , Lot Number 21JBY828 ; DYNDH1641AH, Lot Number 21JBE248 ; DYNDH1641AH, Lot Number 21JBY828 ; DYNDH1798, Lot Number 2022112990; DYNDH1921, Lot Number 23KBC196; DYNDV1588F, Lot Number 2019022090; DYNDV1588F, Lot Number 2019041890; DYNDV1588F, Lot Number 2019090390; DYNDV1588F, Lot Number 2020012890; DYNDV1588G , Lot Number 22GBL908 ; DYNDV1588G , Lot Number 22HBN586 ; DYNDV1588G , Lot Number 22JBI927 ; DYNDV1588G , Lot Number 22LBK218 ; DYNDV1588G , Lot Number 23ABJ940 ; DYNDV1588G , Lot Number 23EBB512 ; DYNDV1588G , Lot Number 23EBU397 ; DYNDV1588G , Lot Number 23IBU991 ; DYNDV1588G , Lot Number 23KBS797 ; DYNJ84749, Lot Number 23HBE651 ; DYNJ84749, Lot Number 23JBD780 ; MNS12670A, Lot Number 2022112990; MNS8915, Lot Number 21GBS360 ; MNS8915, Lot Number 21HBU417 ; MNS8915, Lot Number 21JBI844 ; MNS8915, Lot Number 21JBY844 ; MNS8915, Lot Number 21LBO003 ; MNS8915, Lot Number 21LBS501 ; MNS8915, Lot Number 22CBY070 ; MNS8915, Lot Number 22HBA169 ; MNS8915, Lot Number 22HBT299 ; MNS8915, Lot Number 22IBR400 ; MNS8915, Lot Number 22KBV233 ; MNS8915, Lot Number 23ABF223 ; MNS8915, Lot Number 23CBT546 ; MNS8915, Lot Number 23DBA141 ; MNS8915, Lot Number 23EBF405 ; MNS8915, Lot Number 23FBF145 ; MNS8915, Lot Number 23GBH740 ; MNS8915, Lot Number 23IBL050 ; MNS8915, Lot Number 23JBK017 ; MNS8915, Lot Number 23LBE535 ; MNS8915, Lot Number 24ABQ710 ; MNS8915H , Lot Number 21GBS360 ; MNS8915H , Lot Number 21HBU417 ; MNS8915H , Lot Number 21JBI844 ; MNS8915H , Lot Number 21JBY844 ; MNS8915H , Lot Number 21LBO003 ; MNS8915H , Lot Number 21LBS501 ; MNS8915H , Lot Number 22CBY070 ; MNS8915H , Lot Number 22HBA169 ; MNS8915H , Lot Number 22HBT299 ; MNS8915H , Lot Number 22IBR400 ; MNS8915H , Lot Number 22KBV233 ; MNS8915H , Lot Number 23ABF223 ; MNS8915H , Lot Number 23CBT546 ; MNS8915H , Lot Number 23DBA141 ; MNS8915H , Lot Number 23EBF405 ; MNS8915H , Lot Number 23FBF145 ; MNS8915H , Lot Number 23GBH740 ; MNS8915H , Lot Number 23IBL050 ; MNS8915H , Lot Number 23JBK017 ; MNS8915H , Lot Number 23LBE535 ; MNS8915H , Lot Number 24ABQ710 ; SUT20955, Lot Number 2020012890

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.

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