Windstone Medical Packaging, Inc.

FDA Regulatory Profile

Windstone Medical Packaging, Inc. appears in FDA public data with 336 recalls — including 10 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2816-2026, Class II) was initiated on June 17, 2026.

Summary

Total Recalls
336 (10 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2816-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part NumbeJune 17, 2026
Z-2819-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 0087June 17, 2026
Z-2815-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMSJune 17, 2026
Z-2814-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, PartJune 17, 2026
Z-2812-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683June 17, 2026
Z-2813-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot EpJune 17, 2026
Z-2817-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMSJune 17, 2026
Z-2818-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, PJune 17, 2026
Z-2801-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMSJune 8, 2026
Z-2799-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10June 8, 2026
Z-2800-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12June 8, 2026
Z-2802-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack NumbJune 8, 2026
Z-2621-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kitMay 21, 2026
Z-2619-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kitMay 21, 2026
Z-2620-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kiMay 21, 2026
Z-2622-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kitMay 21, 2026
Z-2307-2026Class IIAligned Medical AMS16835 Fluids Kit RXApril 27, 2026
Z-2066-2026Class ICustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with RotatingApril 2, 2026
Z-1919-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14433March 11, 2026
Z-1920-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994March 11, 2026