Z-2815-2026Class II

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461

Name: Z-2815-2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Creator: Windstone Medical Packaging, Inc.
Published: 2026-06-17
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-06-17 / Open, Classified / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 on 2026-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2815-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-07-27
Recalling firm: Windstone Medical Packaging, Inc.
Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Aligned Medical Solutions (AMS) issues an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/17/2026 via email. The notice explained the issue, potential risk, and requested the following: "AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: 'RECALL NOTICE ELEVARIS announced the recall of Lidocaine 5mL Ampules contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. " At the time the kit is opened for use any Elevaris Lidocaine 5mL Ampule(s) should be identified and set aside. " The recalled Elevaris Lidocaine should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.' 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to [email protected] even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Lidocaine Ampules are needed." for questions or concerns, please do not hesitate to contact us at [email protected].
Quantity in commerce: 60 kits
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.
Product codes and lots: UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2815-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2812-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2813-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2814-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2815-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2816-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2817-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2818-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27
Z-2819-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-27

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)