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Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAP...

FDA Device Recall #Z-2752-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-2752-2024
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 procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475

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

Lot / Code Information

MNS11965A, Lot Number 2023120190; MNS12670A, Lot Number 2022030490; CIT6860A, Lot Number 2022111480; CIT6715, Lot Number 2022080190; DYNDA2271, Lot Number 2022082290; CIT7020, Lot Number 2023051290; CIT7210, Lot Number 2023073190; CIT6720A, Lot Number 2023092690; CIT6665, Lot Number 2024021990; MNS11965A, Lot Number 21CBA170 ; CIT6050 , Lot Number 22FMC986 ; CIT6050 , Lot Number 22JMG259 ; CIT6050 , Lot Number 23BMH919 ; CIT6050 , Lot Number 23CME567 ; CIT6050 , Lot Number 23HMG612 ; CIT6050 , Lot Number 23HMH514 ; CIT6050 , Lot Number 23JMI036 ; CIT6925, Lot Number 2023112190; CIT6255 , Lot Number 23BBP310 ; CIT6255 , Lot Number 23DBD372 ; CIT6255 , Lot Number 23KBD873 ; CIT6255 , Lot Number 24ABC630 ; CIT6255 , Lot Number 24ABS975 ; SPEC0300B, Lot Number 2022021001; SPEC0300B, Lot Number 2022060250; CIT6780, Lot Number 2022021001; CIT6780, Lot Number 2022060350; CIT6780, Lot Number 2023080990; CIT6920, Lot Number 2023012590; CIT6920, Lot Number 2023042490; CIT6920, Lot Number 2023080190; UVT925, Lot Number 21CBZ075 ; UVT925, Lot Number 23FMB519 ; UVT925, Lot Number 23LMB020 ; CIT4845, Lot Number 2021081850; CIT4845, Lot Number 2022122290; CIT7095, Lot Number 2023031590; MNS9865, Lot Number 2022060650; MNS8250, Lot Number 2023112290; DYNDA2497, Lot Number 2021080950; DYNDA2497, Lot Number 2021092050; DYNDA2497, Lot Number 2022030750; DYNDA2497, Lot Number 2022041150; DYNDA2497, Lot Number 2022052350; DYNDA2497, Lot Number 2022120790; DYNDA2497, Lot Number 2022120890; DYNDA2497, Lot Number 2023011290; DYNDA2497, Lot Number 2023080990; DYNDA2497, Lot Number 2023092690; DYNDA2497, Lot Number 2023120790; DYNDA2497, Lot Number 2024021990; DYNDA2496, Lot Number 2021091350; DYNDA2496, Lot Number 2023012590; DYNDH1512A, Lot Number 2022083190; DYNDH1512A, Lot Number 2022112290; DYNDH1512A, Lot Number 2022122290; DYNDH1512A, Lot Number 2023033190; UVT3594 , Lot Number 22CBX289 ; UVT3594 , Lot Number 22FBL917 ; UVT3594 , Lot Number 22JBR542 ; UVT3594 , Lot Number 23FBD767 ; UVT3594 , Lot Number 23KBA665 ; UVT3594 , Lot Number 23KBW299 ; UVT3594 , Lot Number 24ABW166 ; UVT170, Lot Number 22FBF267 ; UVT170, Lot Number 22GBH328 ; UVT170, Lot Number 22JBT833 ; UVT170, Lot Number 23ABS911 ; UVT170, Lot Number 23FBK368 ; UVT170, Lot Number 23GBR967 ; UVT170, Lot Number 23LBA508 ; UVT170, Lot Number 23LBV542 ; UVT170, Lot Number 24BBA988 ; UVT170, Lot Number 24BBO747 ; UVT170, Lot Number 21OBA615 ; UVT475, Lot Number 23CMB726 ; UVT475, Lot Number 23KMC231 ; UVT475, Lot Number 23KMJ689 ; UVT475, Lot Number 24AMB343

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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