DeviceSignal · Recall classified
Windstone Medical Packaging, Inc.
FDA classified a device recall on 2026-07-27 · Class II · Z-2816-2026
EventRecall classified
Effective2026-07-27
ClassificationClass II
On 2026-07-27 the FDA classified a device recall from Windstone Medical Packaging, Inc. as Class II. Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX…. Recall Z-2816-2026. The firm initiated it on 2026-06-17. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2816-2026
- Classification
- Class II
- Classified on
- 2026-07-27
- Initiated on
- 2026-06-17
- Firm
- Windstone Medical Packaging, Inc.
- Reason
- Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2816-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
65507f67daa797b0312b4f61c87bdfc7d933ea5232cc1c9a92f9d688b1c808c4- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)