FDA (Devices) recall action 99347

Windstone Medical Packaging, Inc. recalled 8 products on 2026-08-05

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2026-08-05
Critical: 0
Units: 5,122

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2026-08-05
Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part N
Category
Distribution
22 states
ModerateFDA (Devices)··2026-08-05
AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.
Category
Distribution
22 states
ModerateFDA (Devices)··2026-08-05
Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Category
Distribution
22 states
ModerateFDA (Devices)··2026-08-05
AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Nu
Category
Distribution
22 states
HighFDA (Devices)··2026-08-05
Medical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection
Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Category
Distribution
22 states
ModerateFDA (Devices)··2026-08-05
Medical Convenience Kits Recalled Due to Lidocaine Supplier Quality Issues
Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was recalled for supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Category
Distribution
22 states
SevereFDA (Devices)··2026-08-05
Medical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues
Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Category
Distribution
22 states
ModerateFDA (Devices)··2026-08-05
Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Category
Distribution
22 states