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FDA Closes Recall of Windstone Medical Convenience Kits

The FDA has closed the recall action for 7,306 medical convenience kits distributed nationwide by Windstone Medical Packaging, Inc.

2 reports on this incident · first at Aug 19, 2026, 6:33 p.m. ET

By AI ReporterWritten Aug 19, 2026, 6:58 p.m. ET
The Food and Drug Administration has closed its recall action for 7,306 medical convenience kits packaged by , based in , indicating that the agency considers the recall carried out. The official recall, classified as and assigned recall number , was reported on August 5, 2026, following its initiation on June 8, 2026. The recall involved AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits, including Laminectomy Pack, ACDF/Fusion Pack, Spine Pack, Spinal Pack, Lumbar Spine Pack, Anterior Cervical Pack, and ENT Pack procedure kits. The action was initiated due to a Medicom Urgent Medical Device Recall of specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C because of potential unexpected variability of endotoxin levels. Distribution occurred nationwide across AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA. According to FDA definitions, a recall is used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. Agency records list no other enforcement actions for For reference, the identifying codes for the recalled packs include: - Laminectomy Pack AMS13574A (UDI B098AMS13574A0, Lot Numbers: 235911, 236897) - ACDF/Fusion Pack AMS14710B (UDI B098AMS14710B0, Lot Numbers: 224717, 230666, 213914, 236351) - Spine Pack AMS14991A (UDI B098AMS14991A0, Lot Numbers: 215450, 230108) - Spine Pack AMS14991B (UDI B098AMS14991B0, Lot Numbers: 233346) - Spinal Pack AMS16278 (UDI B098AMS162780, Lot Numbers: 219872, 222999, 226497, 229309, 236465, 237544, 238613) - Spine Pack AMS16499 (UDI B098AMS164990, Lot Numbers: 223361, 225039, 236666, 240344, 241412) - Lumbar Spine Pack AMS17336 (UDI B098AMS173360, Lot Numbers: 233541, 240967) - Laminectomy Pack AMS17945 (UDI B098AMS179450, Lot Numbers: 235478, 240779, 241565) - Anterior Cervical Pack AMS17946 (UDI B098AMS179460, Lot Numbers: 235954, 239092, 241514) - Spine Pack AMS3150F (UDI B098AMS3150F0, Lot Numbers: 242374) - Spine Pack AMS5451D (UDI B098AMS5451D0, Lot Numbers: 222621, 224568, 238089, 238575, 242113) - ENT Pack AMS9771 (UDI B098AMS97710)

Earlier reports

  1. Aug 19, 2026, 6:33 p.m. ETFirst report

    FDA Enforcement Report Details Class II Recall of Medical Convenience Kits

    An FDA enforcement report with a report date of 2026-08-05 lists an ongoing Class II recall by Windstone Medical Packaging, Inc., of Billings, covering 7306 units of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits. The recall carries FDA recall number Z-2802-2026 and was initiated on 2026-06-08. The report lists the status as Ongoing.

    The report gives the reason as follows: "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." The stray character in "Ritmed¿" appears that way in the record as published.

    The report identifies 14 kit configurations: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771.

    Distribution is given as: "US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA."

    The identifying codes are printed in the record as follows:

    • 1) Pack Number AMS13574A, UDI B098AMS13574A0
    • Lot Numbers: 235911, 236897. 2) Pack Number AMS14710B, UDI B098AMS14710B0
    • Lot Numbers: 224717, 230666, 213914, 236351. 3) Pack Number AMS14991A, UDI B098AMS14991A0
    • Lot Numbers: 215450, 230108. 4) Pack Number AMS14991B, UDI B098AMS14991B0
    • Lot Numbers: 233346. 5) Pack Number AMS16278, UDI B098AMS162780
    • Lot Numbers: 219872, 222999, 226497, 229309, 236465, 237544, 238613. 6) Pack Number AMS16499, UDI B098AMS164990
    • Lot Numbers: 223361, 225039, 236666, 240344, 241412. 8) Pack Number AMS17336, UDI B098AMS173360
    • Lot Numbers: 233541, 240967. 9) Pack Number AMS17945, UDI B098AMS179450
    • Lot Numbers: 235478, 240779, 241565. 10) Pack Number AMS17946, UDI B098AMS179460
    • Lot Numbers: 235954, 239092, 241514. 11) Pack Number AMS3150F, UDI B098AMS3150F0
    • Lot Numbers: 242374. 13) Pack Number AMS5451D, UDI B098AMS5451D0
    • Lot Numbers: 222621, 224568, 238089, 238575, 242113. 14) Pack Number AMS9771, UDI B098AMS97710

    As published, that field runs the lot numbers for one entry into the pack number of the next, includes no entries numbered 7 or 12, and ends without lot numbers after the entry for AMS9771.

    This account is drawn entirely from the fields of the enforcement report above. Those fields do not include adverse-event information, instructions to affected facilities, or a firm contact.

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Revision history

  1. Version 119 Aug 2026, 22:33current

    First published.

  2. Version 119 Aug 2026, 22:58current

    First published.

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