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RecallWatchMedical Device Safety
Class IIOngoingZ-1461-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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;

Lot / code information

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

What the firm is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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