Windstone Aligned Medical AMS16835 Fluids Kit Recall: Quality Issues

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Contact the company & request your remedy

Recalling firmWindstone Medical Packaging, Inc.1602 4th Ave N · Billings, MT 59101-1521

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Windstone Medical is recalling Aligned Medical AMS16835 Fluids Kits because they contain lidocaine injection that was recalled by a supplier for quality issues. This affects specific lot numbers and may pose risks if the injection is used improperly.

Why it’s dangerous

The lidocaine injection was recalled by a supplier due to quality issues, which could lead to improper medical use if the kit is used without the supplier's correction. The exact nature of the quality issue is not specified in the recall notice.

Who’s affected

Healthcare providers and patients using the Aligned Medical AMS16835 Fluids Kit with the listed lot numbers are affected. Those handling the kit for medical procedures are at higher risk.

How to tell if you have this one

Check the lot numbers on the kit: 233828, 236048, 236359, 236662, 238580, 239934, or 239935. The product is labeled as Aligned Medical AMS16835 Fluids Kit RX.

Brand
Windstone Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify the lot number on the kit to see if it matches the affected numbers: 233828, 236048, 236359, 236662, 238580, 239934, or 239935.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The lidocaine injection included in the kit was recalled by a supplier for quality issues.

What lot numbers are affected?

Lot numbers 233828, 236048, 236359, 236662, 238580, 239934, and 239935.

Do I need to stop using the kit?

The recall notice does not specify a stop-use instruction, so you can continue using it if the lot number is not affected.

Take action

Contact Windstone Medical

We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2307-2026 — Windstone Medical Windstone Medical

Hello,

I own a Windstone Medical that is covered by recall Z-2307-2026 from Windstone Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2307-2026 (April 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2307-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX

Recall notice