Windstone Medical Packaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
320 (6 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
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-1921-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AMarch 11, 2026
Z-1920-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994March 11, 2026
Z-1919-2026Class IICustom Convenience Kits Pre Op Kit - NS, Part Number AMS14433March 11, 2026
Z-0029-2025Class IIAligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. PAugust 16, 2024
Z-0030-2025Class IIAligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0027-2025Class IIAligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0031-2025Class IIAligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0028-2025Class IIAligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-1081-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEODecember 22, 2023
Z-1080-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEODecember 22, 2023
Z-1082-2024Class IAligned Medical Solutions, Closure Kit, AMS13043, STERILEEODecember 22, 2023
Z-1079-2024Class IAligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEODecember 22, 2023
Z-1621-2023Class IIAligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, StApril 24, 2023
Z-1620-2023Class IIAligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue SApril 24, 2023
Z-1619-2023Class IIAligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, April 24, 2023
Z-0881-2023Class IIVarious Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M CNovember 1, 2022
Z-1101-2022Class IIPrevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenieMarch 21, 2022
Z-0119-2022Class IMonoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following August 19, 2021