Windstone Medical Packaging, Inc. recalls
18 federal recalls on file, showing the 6 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Windstone Medical Packaging, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-09-16FDA-DeviceClass IIWindstone Medical AMS Convenience Kit recalled for detached port parts
Windstone Medical Packaging's AMS Convenience Kit DSAEK Pack contains saline solution bags with blue connector pieces that may detach from the infusion port during normal use. This could allow contamination or improper fluid delivery during ophthalmic surgery.
- 2026-07-08FDA-DeviceClass IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceClass IWindstone AMS Preop Kit recalled for bacterial contamination
Windstone Medical's AMS Preop Kit-NS surgical convenience kits contain Webcol Large Alcohol Prep Pads that were recalled due to bacterial contamination (Paenibacillus phoenicis) discovered during sterilization testing. The contamination was identified by Cardinal Health, the pad manufacturer. About 200 kits with specific lot codes are affected.
- 2026-07-08FDA-DeviceClass IA M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceClass IA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-05-20FDA-DeviceClass IWindstone Custom Convenience Kit recalled for syringe disconnection risk
Windstone Medical Packaging's Custom Convenience Kit (Angio Pack, part numbers AMS6908E and AMS6908F) contains Medline Namic angiographic syringes with a defect: the rotating adapter can unwind during use, causing the syringe to loosen or fully disconnect from the manifold. This disconnection could expose patients to biohazard contamination, blood loss, infection, or air embolism.
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