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Unrated Medical device recall · FDA · Published June 17, 2026

Windstone Medical Packaging Recalls Epi Trays Due to Lidocaine Injection Risk

Windstone Medical Packaging recalls specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues. Affected kits include Dr Fred Chiu Single Shot Epi Trays with listed part numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2813-2026Medical deviceWindstone Medical Packaging ›
✎ GovInfoNow plain-language explainer

Windstone Medical Packaging is recalling specific medical convenience kits that contain Elevaris Lidocaine HCl injection USP. The recall is due to supplier quality issues with the lidocaine injection, which could pose a risk to users. Read more at govinfonow.com/recall/169225-windstone-medical-packaging-recalls-epi-trays-due-to-lidocaine-injection.

Source Summary by GovInfoNow · govinfonow.com/recall/169225-windstone-medical-packaging-recalls-epi-trays-due-to-lidocaine-injection · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2813-2026

Cite this page

“Windstone Medical Packaging Recalls Epi Trays Due to Lidocaine Injection Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/169225-windstone-medical-packaging-recalls-epi-trays-due-to-lidocaine-injection. Based on FDA recall #Z-2813-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2813-2026%22&limit=1).

The FDA announced on June 17, 2026, that Windstone Medical Packaging is recalling AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits due to supplier quality issues with Elevaris Lidocaine HCl injection USP. The agency issued recall number Z-2813-2026 for the voluntary Class II recall affecting 580 kits distributed nationwide.

How to tell if you have it

  • Brand: Windstone Medical Packaging
  • Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits
  • Part Number AMS1095(E, Lot 231043
  • Part Number AMS11296A, Lot 229846
  • Part Number AMS11314A, Lots 216803, 240843
  • Part Number AMS11910A, Lots 230645, 231078
  • Part Number AMS12171, Lots 230958, 231238, 241232
  • Part Number AMS12219A, Lot 217313
  • Part Number AMS12381B, Lot 230948

The hazard

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.

Context

GovInfoNow's records show Windstone Medical Packaging, Inc. has 14 other recalls on record since 2026-07-29. Other recent recalls of similar products include Medline Convenience Kits Recall: Quality Issues with Lidocaine and Bupivacaine (2026-05-06) and Medline Epidural Tray Recall: Lidocaine Ampules Risk from FDA Inspection (2026-05-21).

How to tell if you have this one

Check for kits labeled with part numbers AMS1095(E, AMS11296A, AMS11314A, AMS11910A, AMS12171, AMS12219A, or AMS12381B. Lot numbers 231043, 229846, 216803, 240843, 230645, 231078, 230958, 231238, 241232, 217313, or 230948 are also affected.

  • Brand
    Windstone Medical Packaging
  • Category
    Medical device
FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-2812-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A; UDI/DI B098AMS13683A0, Lot Number 23045115 kits
Z-2813-2026AMS 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.; 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: 230948.580 kits
Z-2814-2026AMS 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.; 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: 231314.950 kits
Z-2815-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461; UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.60 kits
Z-2816-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B; UDI/DI B098DDS1159B0, Lot Numbers: 214412.24 kits
Z-2817-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414; UDI/DI B098AMS124140, Lot Numbers: 230411.100 kits
Z-2818-2026AMS 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.; 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: 217429.3378 kits
Z-2819-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19; UDI/DI B098008786190, Lot Numbers: 230451.15 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your kit has the listed part numbers or lot numbers from the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 22 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jun 17, 202612. FDA classified it Class II: Jul 27, 202623. Published in FDA’s Enforcement Report: Aug 5, 202634. Added to GovInfoNow: Aug 11, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2813-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2813-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA