Medline Convenience Kits recalled due to Lidocaine quality issues
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is FDA Class II, a device recall. The source text does not report any illnesses, injuries, or hospitalizations related to the quality issues, making this a precautionary/quality-control recall without confirmed adverse events.
Plain-English summary
Medline Industries, LP is recalling 250 kits nationwide, comprising two products: the Arterial Line Kit (Model ART890B, Lot 2025102390) and the Ultrasound Guided IV Securement Set (Model IVS3350, Lot 2025102490). These kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules as a component.
The recall was initiated due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site. The source text does not specify the nature of the quality issues, reported illnesses or injuries, or what actions patients or healthcare providers should take regarding existing product use.
Patients and healthcare providers should contact Medline Industries for further guidance regarding this recall and any affected kits already in use.
The recalled product
- Product
- Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
- Manufacturer
- Medline Industries, LP
- Affected units
- 250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) ART890B
- UDI-DI: 10653160360834(each)
- 00653160360837(case)
- Lot Number: 2025102390
- 2) IVS3350
- UDI-DI: 10653160313045(each)
- 00653160313048(case)
- Lot Number: 2025102490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · quality defect
See all →- LowSupernus Recalls Trokendi XR Topiramate Capsules for Dissolution Failure
FDA (Drugs) · 2026-09-09
- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Circumcision Trays recalled due to Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
Similar recalls
- SevereMedline Convenience Kits Medical Devices Recalled for Quality Issues
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Central Line Insertion recalled for quality issues
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits containing anesthesia components recalled for quality issues
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01
- HighMedical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection
FDA (Devices) · 2026-08-05
- SevereMedline Medical Procedure Convenience Kits Recalled Due to Potential Drug Ineffectiveness
FDA (Devices) · 2026-07-29