FDA recall, , Moderate risk
Aligned Medical Fluids Kit
The Aligned Medical AMS16835 Fluids Kit RX contains lidocaine hydrochloride injection with quality issues.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc., of Billings, Montana, began a recall of the Aligned Medical AMS16835 Fluids Kit RX on April 27, 2026, because the kit contained Lidocaine Hydrochloride Injection, USP, that had been recalled by a supplier for quality issues. The FDA added the recall to its Enforcement Report and classified it on June 3, 2026, and it was in the FDA's weekly enforcement report on June 10, 2026.
The recall involves 875 kits distributed nationwide in the states of Illinois and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its lot code is listed.
Aligned Medical AMS16835 Fluids Kit RX
- Lot code
- 233828
- 236048
- 236359
- 236662
- 238580
- 239934
- 239935
Recall details
- Company began the recall
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98957
- Recall number
- Z-2307-2026
- Quantity recalled
- 875 kits
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
