Class II FDA device recall · Z-1461-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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;

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1461-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2025-02-11

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1461-2025 · Source: openFDA enforcement.