Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing 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 classified as FDA Class II (per agency designation), and the source text does not report any illnesses or injuries. The hazard involves "quality issues" that are not explicitly detailed as high-risk pathogenic contamination or structural failure, making this a moderate precautionary recall without reported adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules. The kits affected are: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number I550BF6C, Lot Number 2025102290; and 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number I505BF9C, Lot Number 2025093090.
The recall was initiated due to quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Approximately 510 kits were distributed nationwide in the United States. Consumers and healthcare facilities who have received these kits should discontinue use and contact Medline Industries, LP for further instructions regarding the return or destruction of the affected products.
The recalled product
- Product
- Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Injection Kit
- Hazard
- Affected units
- 510
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) I550BF6C
- UDI-DI: 10653160339748(each)
- 00653160339741(case)
- Lot Number: 2025102290
- 2) I505BF9C
- UDI-DI: 10653160339687(each)
- 00653160339680(case)
- Lot Number: 2025093090
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 with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits containing anesthesia components recalled for quality issues
FDA (Devices) · 2026-07-01
- CriticalMedline C-Section Convenience Kits Recalled Due to Quality Issues in Bupivacaine Component
FDA (Devices) · 2026-07-29
- HighMedical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection
FDA (Devices) · 2026-08-05