CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Medline procedure kits labeled as recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Medline procedure kits labeled as: Billings Clinic SC Head & Neck, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1461-2025
- FDA event ID
- 96373
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2025
- FDA classified
- 26 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Dental Devices
Timeline
| 11 Feb 2025 | Recall initiated by company | |
| 26 Mar 2025 | Classified by FDA | +43 days |
| 2 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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;
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96373This product is part of a recall event; the main page for the event is Medline procedure kits labeled as: Angiography Specials recalled.
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