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Windstone Medical Packaging, Inc. FDA Recalls
39 recalls on file across devices, 10 of them Class I and 37 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BClass IIJul 29, 2026The convenience kits contain .0.9% Sodium Chloride Injection |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164;Class IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159BClass IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; Class IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414Class IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part NuClass IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461Class IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19Class IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683AClass IIJun 17, 2026Windstone Medical Packaging recalled specific items and lots |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack,Class IIJun 8, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Class IIJun 8, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro PClass IIJun 8, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) AClass IIJun 8, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kitClass IMay 21, 2026Kits contain Webcol Large Alcohol Prep Pad which were recall |
| A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kitClass IMay 21, 2026Kits contain Webcol Large Alcohol Prep Pad which were recall |
| A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kitClass IMay 21, 2026Kits contain Webcol Large Alcohol Prep Pad which were recall |
| A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kitClass IMay 21, 2026Kits contain Webcol Large Alcohol Prep Pad which were recall |
| Aligned Medical AMS16835 Fluids Kit RXClass IIApr 27, 2026Lidocaine Hydrochloride Injection, USP, which was recalled b |
| Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA SClass IApr 2, 2026Affected kits contain Medline Namic RA Syringes, which are r |
| Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994Class IIMar 11, 2026The product correction was initiated because B Braun is issu |
| Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AClass IIMar 11, 2026The product correction was initiated because B Braun is issu |
| Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433Class IIMar 11, 2026The product correction was initiated because B Braun is issu |
| Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged inClass IIAug 16, 2024Due to convenience kits containing a kit component that is u |
| Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged Class IIAug 16, 2024Due to convenience kits containing a kit component that is u |
| Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in aClass IIAug 16, 2024Due to convenience kits containing a kit component that is u |
| Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in Class IIAug 16, 2024Due to convenience kits containing a kit component that is u |
| Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in Class IIAug 16, 2024Due to convenience kits containing a kit component that is u |
| Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEOClass IDec 22, 2023Sterility assurance for saline included in surgical kits can |
| Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEOClass IDec 22, 2023Sterility assurance for saline included in surgical kits can |
| Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEOClass IDec 22, 2023Sterility assurance for saline included in surgical kits can |
| Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEOClass IDec 22, 2023Sterility assurance for saline included in surgical kits can |
| Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EOClass IIApr 24, 2023Light handle covers may separate from the light handle (deta |
| Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EOClass IIApr 24, 2023Light handle covers may separate from the light handle (deta |
| Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EOClass IIApr 24, 2023Light handle covers may separate from the light handle (deta |
| Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMSClass IINov 1, 2022Due to Customer Convenience Kits containing 3M Steri-Drape S |
| Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/PClass IIMar 21, 2022Convenience kits contain one or more swab/swabstick drug pro |
| Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical SClass IAug 19, 2021Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by |
| Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover PClass IIApr 8, 2021Angio tubing included within Custom Convenience kits may co |
| Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 CoClass IIApr 8, 2021Angio tubing included within Custom Convenience kits may co |