FDA recall, , Moderate risk
AMS Aligned Medical Solutions Medical Convenience Kits
Medical convenience kits contain Lidocaine HCl injection that may be affected by supplier quality issues.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc. of Billings, Montana, recalled AMS Aligned Medical Solutions medical convenience kits that contain Elevaris Lidocaine HCl injection USP, after Elevaris Medical Devices Inc. recalled the injection due to supplier quality issues. The recall began June 17, 2026, and the FDA classified it on July 27, 2026.
The kits were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington.
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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
AMS Aligned Medical Solutions medical convenience kits
- Lot code
- 230376
- 241103
- 216938
- 240939
- 231314
- UDI-DI
- 00813623010666
- Lot code
- 230816
- 230588
- 230589
- 230590
- 230893
- 241165
- 215784
- 231259
- 241171
- 230680
- 217313
- 240360
- 217431
- 230376
- 241103
- 217790
- 230689
- 230667
- 216398
- 241219
- 241307
- 230737
- 231023
- 241136
- 241031
- 230745
- 230716
- 230851
- 217634
- 217635
- 231235
- 231236
- 240963
- 217055
- 217429
- Lot code
- 231043
- 229846
- 216803
- 240843
- 230645
- 231078
- 230958
- 231238
- 241232
- 217313
- 230948
Some entries omit identifying details. Check the notice to confirm which units are affected.
AMS Aligned Medical Solutions medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
- Lot code
- 230451
AMS Aligned Medical Solutions medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
- Lot code
- 214412
AMS Aligned Medical Solutions medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
- Lot code
- 230411
AMS Aligned Medical Solutions medical convenience kits labeled as: Spinal Kit, Part Number AMS13683A
- Lot code
- 230451
AMS Aligned Medical Solutions medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
- Lot code
- 230658
- 231173
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia, Washington.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Packaging 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
- 99347
- Recall numbers
- Z-2812-2026 to Z-2819-2026
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
