The Recall Desk

FDA (Devices) recall action 99323

Windstone Medical Packaging, Inc. recalled 4 products on 2026-08-05

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2026-08-05
Critical
0
Units
9,617

Why these products were recalled

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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2026-08-05

    Medical convenience kits recalled due to potential endotoxin level variability

    Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 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;
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2026-08-05

    Ritmed Neurological Sponges Recalled Due to Potential Endotoxin Level Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges (Models 55992C to 55998C) because of potential unexpected variability in endotoxin levels.

    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.
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2026-08-05

    Medical Convenience Kits Recalled Over Endotoxin Variability in Neurological Sponges

    Windstone Medical Packaging is recalling 465 AMS medical convenience kits in connection with a Medicom recall of Ritmed Neurological Sponges due to potential endotoxin level variability.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6)
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2026-08-05

    Neurological Sponges Recalled Due to Potential Variability in Endotoxin Levels

    Medicom is recalling specific lots of Ritmed Neurological Sponges (Models 55992C to 55998C) because of potential unexpected variability in endotoxin levels.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6
    Category
    Distribution
    14 states