Recall Z-2307-2026 ยท LRO General Surgery Tray
Windstone Medical Packaging, Inc.
Aligned Medical AMS16835 Fluids Kit RX
| Date | Jun 3, 2026 (initiated Apr 27, 2026) |
| Status | Open, Classified |
| Reason | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: MEDICAL DEVICE RECALL dated 4/27/26 was sent to customers. Please Note: Since AMS manufactured convenience kits that contain Huons Co. Ltd. Pharmacy Lidocaine HCL 1% 5ML SDV, we are extending our recall strategy to the end user level. 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 w |
| Quantity | 875 kits |
| Distribution | US Nationwide distribution in the states of IL, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.