Data Foundry

Medical device recalls 2026

Medline Convenience Kits: 1) ARTERIAL LINE KIT — Class II medical device recall Z-2543-2026

Ongoing recall by Medline Industries, LP, reported 2026-07-08, distributed nationwide. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recal

Recall numberZ-2543-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-05-21
Classified2026-06-29
Reported by FDA2026-07-08
DistributedNationwide (US)
Quantity250 kits
UPC / GTIN / UDI-DI00653160313048, 00653160360837, 10653160313045, 10653160360834
Lot numbers2025102390, 2025102490
Model numbersART890B, IVS3350

Product

Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350

Reason for recall

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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-2543-2026. 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.