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Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; ...

FDA Device Recall #Z-1461-2025 — Class II — February 11, 2025

Recall Summary

Recall Number Z-1461-2025
Classification Class II — Moderate risk
Date Initiated February 11, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 2161 kits

Product Description

Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT PACK, Pack Number DYNJ42564B; 8) ENT PACK, Pack Number DYNJ50572; 9) ENT PACK, Pack Number DYNJ45175B; 10) ENT PACK, Pack Number DYNJ65585A; 11) EP PACK, Pack Number DYNJ59171; 12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A; 13) HEAD & NECK, Pack Number DYNJ902987F; 14) HEAD & NECK PACK, Pack Number DYNJ61295B; 15) HEAD & NECK PACK, Pack Number DYNJ30234B; 16) HEAD & NECK PACK, Pack Number DYNJ50383; 17) HEAD & NECK PACK, Pack Number DYNJ36634K; 18) HEAD & NECK PACK, Pack Number DYNJ66399; 19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I; 20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I; 21) NASAL SINUS PACK-LF, Pack Number DYNJ0751486N; 22) NE NASAL, Pack Number DYNJ03130D; 23) ORL PACK, Pack Number DYNJ63705B; 24) SINUS PACK, Pack Number DYNJ50110B; 25) SINUS PACK, Pack Number DYNJ50110B; 26) T & A PACK, Pack Number DYNJ58811A; 27) THORACIC PACK, Pack Number DYNJ30731M; 28) THYROIDECTOMIE DIAGNOSTIQUE-LF, Pack Number DYNJ42678A; 29) TONSILS & ADENOIDS, Pack Number DYNJ69465; 30) TRANSPHENOIDAL PACK, Pack Number DYNJ46556B;

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 - US Nationwide and the country of Canada.

Lot / Code Information

1) Pack Number DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case), Lot Number 20BDA583A; 2) Pack Number DYNJ37741B: UDI/DI 10193489682212 (each) 40193489682213 (case), Lot Number 20BDB113A; 3) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case), Lot Number 20FBS559A; 4) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case), Lot Number 20FMA565A; 5) Pack Number DYNJ37707D: UDI/DI 10193489258936 (each) 40193489258937 (case), Lot Number 20HKB321A; 6) Pack Number DYNJ64526A: UDI/DI 10193489531589 (each) 40193489531580 (case), Lot Number 20HMC644A; 7) Pack Number DYNJ62755B: UDI/DI 10193489296792 (each) 40193489296793 (case), Lot Number 20HMD066A; 8) Pack Number DYNJ61634B: UDI/DI 10888277756168 (each) 40888277756169 (case), Lot Number 20HMD167A; 9) Pack Number DYNJ83129: UDI/DI 10193489366815 (each) 40193489366816 (case), Lot Number 20JKA848A; 10) Pack Number DYNJ35906F: UDI/DI 10193489718577 (each) 40193489718578 (case), Lot Number 20LBI228Z; 11) Pack Number DYNJ35906F: UDI/DI 10193489397598 (each) 40193489397599 (case), Lot Number 20LBS935Z; 12) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A; 13) Pack Number DYNJ54684B: UDI/DI 10193489551068 (each) 40193489551069 (case), Lot Number 21IMD870A; 14) Pack Number DYNJ44692D: UDI/DI 10193489909869 (each) 40193489909860 (case), Lot Number 21IME024A; 15) Pack Number DYNJ0190688Q: UDI/DI 10193489322644 (each) 40193489322645 (case), Lot Number 21IME395A; 16) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A; 17) Pack Number DYNJ30196F: UDI/DI 10193489976625 (each) 40193489976626 (case), Lot Number 21IME728A; 18) Pack Number DYNJ51796G: UDI/DI 10889942651887 (each) 40889942651888 (case), Lot Number 21IME769A; 19) Pack Number DYNJ39734D: UDI/DI 10193489303940 (each) 40193489303941 (case), Lot Number 21IMH101A; 20) Pack Number DYNJ64208: UDI/DI 10193489917703 (each) 40193489917704 (case), Lot Number 22FBW094A; 21) Pack Number DYNJ43522C: UDI/DI 10195327176310 (each) 40195327176311 (case), Lot Number 22GBL783M; 22) Pack Number DYNJ59765A: UDI/DI 10195327155780 (each) 40195327155781 (case), Lot Number 22GBM456Z; 23) Pack Number DYNJ54965: UDI/DI 10889942275069 (each) 40889942275060 (case), Lot Number 22GMA060Z; 24) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (case), Lot Number 22JBY434A; 25) Pack Number DYNJ45861B: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC920Z; 26) Pack Number DYNJ27165V: UDI/DI 10888277208872 (each) 40888277208873 (case), Lot Number 23CBN716A; 27) Pack Number DYNJ35449G: UDI/DI 10195327040239 (each) 40195327040230 (case), Lot Number 23CBO497A; 28) Pack Number DYNJ62673A: UDI/DI 10195327026592 (each) 40195327026593 (case), Lot Number 23CDC561A; 29) Pack Number DYNJ37636L: UDI/DI 10195327299064 (each) 40195327299065 (case), Lot Number 23CLA003A; 30) Pack Number DYNJ24637J: UDI/DI 10195327383596 (each) 40195327383597 (case), Lot Number 23GMC950A

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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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