FDA Reports Class II Recall of Medical Convenience Kits
Windstone Medical Packaging recalled 3378 medical convenience kits containing Elevaris Lidocaine HCl injection due to supplier quality issues.
By AI ReporterWritten Aug 20, 2026, 3:44 a.m. ET
On August 5, 2026, official FDA enforcement records reported an recall of medical convenience kits initiated on June 17, 2026, by , based in . The recall covers distributed nationwide in AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA.
According to FDA enforcement report records for recall number , Windstone Medical Packaging issued the recall for specific items and lots of AMS ALIGNED MEDICAL SOLUTIONS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. A recall is defined by the FDA as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled products encompass 23 kit descriptions: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164, UDI/DI B098AMS101640, Lot 230816; 2) NY Tray - RX, Part Number AMS10276A, UDI/DI B098AMS10276A0, Lots 230588, 230589, 230590, 230893, 241165; 3) NYC Tray - RX, Part Number AMS10281B, UDI/DI B098AMS10281B0, Lots 215784, 231259, 241171; 4) Vein Pack - RX, Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot 230680; 5) Radiology Tray-RX, Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot 217313; 6) Custom Pack - RX, Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot 240360; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700, UDI/DI B098AMS137000, Lot 217431; 8) Arthrogram Tray - RX, Part Number AMS13755A, UDI/DI B098AMS13755A0, Lots 230376, 241103; 9) Myelogram Tray - RX, Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot 217790; 10) Arthrogram Tray - RX, Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot 230689; 11) Vein Pack - RX, Part Number AMS15270, UDI/DI B098AMS152700, Lot 230667; 12) Myelogram Tray - RX, Part Number AMS15298, UDI/DI B098AMS152980, Lot 216398; 13) Loop Pack - RX, Part Number AMS15643, UDI/DI B098AMS156430, Lot 241219; 14) Basic Biopsy Tray - RX, Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot 241307; 15) Pain Pack -RX, Part Number AMS17021, UDI/DI B098AMS170210, Lots 230737, 231023; 16) Pain Tray -RX, Part Number AMS17817, UDI/DI B098AMS178170, Lot 241136; 17) Vasectomy Pack - RX, Part Number AMS18226, UDI/DI B098AMS182260, Lot 241031; 18) Arthrogram Tray- RX, Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot 230745; 19) Custom Pack - RX, Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot 230716; 20) Basic Procedure Pack - RX, Part Number AMS5497, UDI/DI B098AMS54970, Lot 230851; 21) Basic Pack - RX, Part Number AMS8130C, UDI/DI B098AMS8130C0, Lots 217634, 217635, 231235, 231236, 240963; 22) Supply Kit - RX, Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot 217055; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB, UDI/DI 00813623010666, Lot 217429.
FDA recall history database records show no other enforcement action for
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