The Recall Desk
HighFDA (Devices)·Z-2307-2026·Announced 2026-06-10

[pending] Aligned Medical AMS16835 Fluids Kit RX

Pending LLM rewrite. Source: FDA_DEVICE Z-2307-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
Aligned Medical AMS16835 Fluids Kit RX
Manufacturer
Windstone Medical Packaging, Inc.

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)

  • UDI-DI: B098AMS168350
  • Lot Numbers: 233828
  • 236048
  • 236359
  • 236662
  • 238580
  • 239934
  • 239935

Distribution

Distributed nationwide across the United States.