Recall Z-2619-2026 ยท LRO General Surgery Tray
Windstone Medical Packaging, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
| Date | Jul 1, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | AMS ALIGNED MEDICAL SOLUTIONS issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/21/2026 via email. The notice explained the issue, potential risk, and requested the following: "AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each |
| Quantity | 1080 kits |
| Distribution | US Nationwide distribution in the states of PA, GA, CA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.