HIGHFDA DEVICE

Aligned Medical AMS16835 Fluids Kit RX

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

Windstone Medical PackagingHealth & Personal CareMedical DevicesUDI-DI: B098AMS168350Lot Numbers: 233828236048

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 27, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 27, 2026
Hazard Level
HIGH
Brand
Windstone Medical Packaging
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Windstone Medical Packaging
Model numbers
UDI-DI: B098AMS168350, Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 27, 2026

  2. Reported by FDA DEVICE

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Windstone Medical Packaging, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

Aligned Medical AMS16835 Fluids Kit RX. Reason: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.. Classification: Class II. Quantity: 875 kits. Distribution: US Nationwide distribution in the states of IL, VA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: B098AMS168350
Lot Numbers: 233828
236048
236359
236662
+3 more
Affected States
ALL
Report Date
June 10, 2026
Recall Status
ACTIVE