Z-2800-2026Class II

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT...

Name: Z-2800-2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT...
Creator: Windstone Medical Packaging, Inc.
Published: 2026-06-08
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-06-08 / 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: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack... on 2026-06-08. FDA classified it as Class II and gives the reason as "The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected...". 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-2800-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-24
Recalling firm: Windstone Medical Packaging, Inc.
Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
Product code: OGR Ear, Nose, And Throat Surgical Tray
Reason for recall: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Aligned Medical Solutions (AMS) issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/8/2026 via email. The notice explained the issue, potential risk, and requested the following actions: identify and quarantine affected product, affix the sticker which reads: "RECALL NOTICE Medicom announced the recall of Ritmed Neurological Sponges 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 Medicom-Ritmed Neurological Sponges should be identified and set aside. " The recalled Medicom-Ritmed Neurological Sponges should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Complete the recall reply form and return it via email to: [email protected] even if you have no affected product on hand. Those further distributing the product were directed to notify their distribution partners. For questions contact [email protected].
Quantity in commerce: 919 units
Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Product codes and lots: 1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2800-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2799-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24
Z-2800-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24
Z-2801-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24
Z-2802-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24

Product code OGR

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)