Unrated Medical device recall · FDA · Published April 27, 2026

Windstone Aligned Medical AMS16835 Fluids Kit Recall: Quality Issues

Windstone Medical recalls AMS16835 Fluids Kit due to quality issues with lidocaine injection. Affected lot numbers include 233828, 236048, 236359, 236662, 238580, 239934, 239935.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2307-2026Medical device Windstone Medical ›

Recall notice

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

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/49373-windstone-aligned-medical-ams16835-fluids-kit-recall-quality-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/49373-windstone-aligned-medical-ams16835-fluids-kit-recall-quality-issues · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2307-2026

Cite this page

“Windstone Aligned Medical AMS16835 Fluids Kit Recall: Quality Issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49373-windstone-aligned-medical-ams16835-fluids-kit-recall-quality-issues. Based on FDA recall #Z-2307-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2026%22&limit=1).

The FDA announced on April 27, 2026, that Windstone Medical Packaging, Inc. is recalling Aligned Medical AMS16835 Fluids Kit RX due to quality issues with included Lidocaine Hydrochloride Injection, USP. The agency issued recall number Z-2307-2026 for the voluntary Class II action.

How to tell if you have it

Brand: Windstone Medical
Product: Aligned Medical AMS16835 Fluids Kit RX
UDI-DI: B098AMS168350
Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Quantity: 875 kits

The hazard

The recall involves Lidocaine Hydrochloride Injection, USP, which was included in custom convenience kits. This specific injection was recalled by a supplier for quality issues.

Context

GovInfoNow's records show Windstone Medical Packaging, Inc. has 14 other recalls on record since October 24, 2017. Other recent recalls of similar products include Windstone AMS Convenience Kit (July 29, 2026), Windstone AMS Medical Kits (June 17, 2026), and Windstone Medical Packaging Spine Kits (June 8, 2026). Similar recent recalls also include Medline Convenience Kits (May 6, 2026) and Medline LUMBAR PUNCTURE CHOICE Kits (May 21, 2026).

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.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of IL, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, Virginia.

Recall timeline

FDA published this recall 44 days after the firm started it.

Apr 27, 2026Firm started the recall
Jun 3, 2026FDA classified it Class II
Jun 10, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/49373-windstone-aligned-medical-ams16835-fluids-kit-recall-quality-issues">Windstone Aligned Medical AMS16835 Fluids Kit Recall: Quality Issues (GovInfoNow)</a>

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.