Z-2307-2026Class II

Aligned Medical AMS16835 Fluids Kit RX

Name: Z-2307-2026 Aligned Medical AMS16835 Fluids Kit RX
Creator: Windstone Medical Packaging, Inc.
Published: 2026-04-27
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of Aligned Medical AMS16835 Fluids Kit RX on 2026-04-27. FDA classified it as Class II and gives the reason as "Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits". 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-2307-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-27
Posted: 2026-06-03
Recalling firm: Windstone Medical Packaging, Inc.
Product: Aligned Medical AMS16835 Fluids Kit RX
Product code: LRO General Surgery Tray
Reason for recall: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE RECALL dated 4/27/26 was sent to customers. Please Note: Since AMS manufactured convenience kits that contain Huons Co. Ltd. Pharmacy Lidocaine HCL 1% 5ML SDV, we are extending our recall strategy to the end user level. 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 Huons Co. Ltd. announced the recall of 73293-0001-2 Lidocaine Hydrochloride Injection 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 Huons Co. Ltd. Lidocaine Hydrochloride Injection should be identified, and quarantined. " The recalled Huons Co. Ltd. Lidocaine Hydrochloride Injection should be rendered unusable to protect against inadvertent use and returned to AMS. 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 Huons Co. Ltd. product is needed. If you have any questions or concerns please do not hesitate to contact us at [email protected]. Dear Customer, This letter is to describe the process for placing the "Recall Notice
Quantity in commerce: 875 kits
Distribution: US Nationwide distribution in the states of IL, VA.
Product codes and lots: UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2307-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2307-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

Product code LRO

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)