Data Foundry

Medical device recalls 2025

Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK — Class II medical device recall Z-1461-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L

Recall numberZ-1461-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-02-11
Classified2025-03-26
Reported by FDA2025-04-02
DistributedNationwide (US)
Countries outside the USCA
Quantity2,161 kits
Reason classespackaging, device malfunction
UPC / GTIN / UDI-DI10193489258936, 10193489276510, 10193489296792, 10193489303940, 10193489322644, 10193489366815, 10193489369892, 10193489397598, 10193489531589, 10193489551068, 10193489682212, 10193489718577, 10193489805413, 10193489909869, 10193489917703, 10193489976625, 10195327026592, 10195327040239, 10195327155780, 10195327176310, 10195327230081, 10195327299064, 10195327383596, 10888277208872, 10888277546394 and 35 more
Lot numbers20BDA583A, 20BDB113A, 20FBS559A, 20FMA565A, 20HKB321A, 20HMC644A, 20HMD066A, 20HMD167A, 20JKA848A, 20LBI228Z, 20LBS935Z, 21BBI544A, 21IMD870A, 21IME024A, 21IME395A, 21IME484A, 21IME728A, 21IME769A, 21IMH101A, 22FBW094A, 22GBL783M, 22GBM456Z, 22GMA060Z, 22JBY434A, 22KBC920Z, 23CBN716A, 23CBO497A, 23CDC561A, 23CLA003A, 23GMC950A

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.