AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
- Agency
- FDA Device
- Recall date
- Jun 17, 2026
- Status
- Ongoing
- Company
- Windstone Medical Packaging, Inc.
1. What product was recalled?
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E
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 Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.
Quantity: 580 kits
Code or lot text: Part Number AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot Numbers: 229846; Part Number AMS11314A, UDI/DI B098AMS11314A0; Lot Numbers: 216803, 240843; Part Number AMS11910A, UDI/DI B098AMS11910A0; Lot Numbers: 230645, 231078; Part Number AMS12171, UDI/DI B098AMS121710; Lot Numbers: 230958, 231238, 241232; Part Number AMS12219A, UDI/DI B098AMS12219A0; Lot Numbers: 217313; Part Number AMS12381B, UDI/DI B098AMS12381B0; Lot Numbers: 230948.
- LOT
- 231078
- LOT
- 231238
- LOT
- 240843
- LOT
- 241232
- LOT
- Lot Numbers: 216803
- LOT
- Lot Numbers: 217313
- LOT
- Lot Numbers: 229846
- LOT
- Lot Numbers: 230645
- LOT
- Lot Numbers: 230948.
- LOT
- Lot Numbers: 230958
- LOT
- Lot Numbers: 231043
- LOT
- Part Number AMS1095(E
- LOT
- Part Number AMS11296A
- LOT
- Part Number AMS11314A
- LOT
- Part Number AMS11910A
- LOT
- Part Number AMS12171
- LOT
- Part Number AMS12219A
- LOT
- Part Number AMS12381B
- LOT
- UDI/DI B098AMS1095(E0
- LOT
- UDI/DI B098AMS11296A0
- LOT
- UDI/DI B098AMS11314A0
- LOT
- UDI/DI B098AMS11910A0
- LOT
- UDI/DI B098AMS121710
- LOT
- UDI/DI B098AMS12219A0
- LOT
- UDI/DI B098AMS12381B0
- RECALL-NUMBER
- Z-2813-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164
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 Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.
Quantity: 3378 kits
Code or lot text: Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers: 230816; Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers: 230588, 230589, 230590, 230893, 241165; Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers: 215784, 231259, 241171; Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers: 230680; Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers: 217313; Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers: 240360; Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers: 217431; Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers: 230376, 241103; Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers: 217790; Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers: 230689; Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers: 230667; Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers: 216398; Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers: 241219; Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers: 241307; Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers: 230737, 231023; Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers: 241136; Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers: 241031; Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers: 230745; Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers: 230716; Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers: 230851; Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers: 217634, 217635, 231235, 231236, 240963; Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers: 217055; Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers: 217429.
- LOT
- 217635
- LOT
- 230589
- LOT
- 230590
- LOT
- 230893
- LOT
- 231023
- LOT
- 231235
- LOT
- 231236
- LOT
- 231259
- LOT
- 240963
- LOT
- 241103
- LOT
- 241165
- LOT
- 241171
- LOT
- Lot Numbers: 215784
- LOT
- Lot Numbers: 216398
- LOT
- Lot Numbers: 217055
- LOT
- Lot Numbers: 217313
- LOT
- Lot Numbers: 217429.
- LOT
- Lot Numbers: 217431
- LOT
- Lot Numbers: 217634
- LOT
- Lot Numbers: 217790
- LOT
- Lot Numbers: 230376
- LOT
- Lot Numbers: 230588
- LOT
- Lot Numbers: 230667
- LOT
- Lot Numbers: 230680
- LOT
- Lot Numbers: 230689
- LOT
- Lot Numbers: 230716
- LOT
- Lot Numbers: 230737
- LOT
- Lot Numbers: 230745
- LOT
- Lot Numbers: 230816
- LOT
- Lot Numbers: 230851
- LOT
- Lot Numbers: 240360
- LOT
- Lot Numbers: 241031
- LOT
- Lot Numbers: 241136
- LOT
- Lot Numbers: 241219
- LOT
- Lot Numbers: 241307
- LOT
- Part Number AMS10164
- LOT
- Part Number AMS10276A
- LOT
- Part Number AMS10281B
- LOT
- Part Number AMS11398C
- LOT
- Part Number AMS1217A
- LOT
- Part Number AMS12757B
- LOT
- Part Number AMS13700
- LOT
- Part Number AMS13755A
- LOT
- Part Number AMS14805A
- LOT
- Part Number AMS15071A
- LOT
- Part Number AMS15270
- LOT
- Part Number AMS15298
- LOT
- Part Number AMS15643
- LOT
- Part Number AMS15662A
- LOT
- Part Number AMS17021
- LOT
- Part Number AMS17817
- LOT
- Part Number AMS18226
- LOT
- Part Number AMS2886(A
- LOT
- Part Number AMS3081C
- LOT
- Part Number AMS5497
- LOT
- Part Number AMS8130C
- LOT
- Part Number AMS9521A
- LOT
- Part Number VK0003MB
- LOT
- UDI/DI 00813623010666
- LOT
- UDI/DI B098AMS101640
- LOT
- UDI/DI B098AMS10276A0
- LOT
- UDI/DI B098AMS10281B0
- LOT
- UDI/DI B098AMS11398C0
- LOT
- UDI/DI B098AMS1217A0
- LOT
- UDI/DI B098AMS12757B0
- LOT
- UDI/DI B098AMS137000
- LOT
- UDI/DI B098AMS13755A0
- LOT
- UDI/DI B098AMS14805A0
- LOT
- UDI/DI B098AMS15071A0
- LOT
- UDI/DI B098AMS152700
- LOT
- UDI/DI B098AMS152980
- LOT
- UDI/DI B098AMS156430
- LOT
- UDI/DI B098AMS15662A0
- LOT
- UDI/DI B098AMS170210
- LOT
- UDI/DI B098AMS178170
- LOT
- UDI/DI B098AMS182260
- LOT
- UDI/DI B098AMS2886(A0
- LOT
- UDI/DI B098AMS3081C0
- LOT
- UDI/DI B098AMS54970
- LOT
- UDI/DI B098AMS8130C0
- LOT
- UDI/DI B098AMS9521A0
- RECALL-NUMBER
- Z-2818-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A
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.
Quantity: 950 kits
Code or lot text: Part Number AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers: 230376, 241103; Part Number AMS2009, UDI/DI B098AMS20090, Lot Numbers: 216938, 240939; Part Number AMS3224, UDI/DI B098AMS32240, Lot Numbers: 231314.
- LOT
- 240939
- LOT
- 241103
- LOT
- Lot Numbers: 216938
- LOT
- Lot Numbers: 230376
- LOT
- Lot Numbers: 231314.
- LOT
- Part Number AMS13975A
- LOT
- Part Number AMS2009
- LOT
- Part Number AMS3224
- LOT
- UDI/DI B098AMS13975A0
- LOT
- UDI/DI B098AMS20090
- LOT
- UDI/DI B098AMS32240
- RECALL-NUMBER
- Z-2814-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Quantity: 60 kits
Code or lot text: UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.
- LOT
- 231173.
- LOT
- Lot Numbers: 230658
- LOT
- UDI/DI B098AMS94610
- RECALL-NUMBER
- Z-2815-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Quantity: 100 kits
Code or lot text: UDI/DI B098AMS124140, Lot Numbers: 230411.
- LOT
- Lot Numbers: 230411.
- LOT
- UDI/DI B098AMS124140
- RECALL-NUMBER
- Z-2817-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Quantity: 24 kits
Code or lot text: UDI/DI B098DDS1159B0, Lot Numbers: 214412.
- LOT
- Lot Numbers: 214412.
- LOT
- UDI/DI B098DDS1159B0
- RECALL-NUMBER
- Z-2816-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Quantity: 15 kits
Code or lot text: UDI/DI B098008786190, Lot Numbers: 230451.
- LOT
- Lot Numbers: 230451.
- LOT
- UDI/DI B098008786190
- RECALL-NUMBER
- Z-2819-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Quantity: 15 kits
Code or lot text: UDI/DI B098AMS13683A0, Lot Number 230451
- LOT
- Lot Number 230451
- LOT
- UDI/DI B098AMS13683A0
- RECALL-NUMBER
- Z-2812-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Arizona: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- California: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Colorado: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Connecticut: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Florida: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Georgia: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Illinois: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Kansas: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Louisiana: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Massachusetts: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Maryland: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Minnesota: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Missouri: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- New Hampshire: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- New Jersey: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Nevada: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- New York: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Oregon: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Pennsylvania: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Texas: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Virginia: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Washington: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.