The Recall Desk
HighFDA (Devices)·Z-2801-2026·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen/contaminant (endotoxins) in a medical device, which poses a risk of harm, though no illnesses have been reported.

Plain-English summary

Medicom is recalling specific lots of Ritmed Neurological Sponges, non-sterile models 55992C through 55998C. The recall was initiated due to the potential for unexpected variability in the endotoxin levels found on the products.

This recall affects specific lots of the non-sterile neurological sponges. Users should check their inventory for the affected models and lot numbers.

Consumers and medical professionals should follow standard protocols for managing recalled medical devices and contact the manufacturer for further guidance.

The recalled product

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
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Sponges
Hazard
Affected units
927

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) Pack Number AMS12195C
  • UDI B098AMS12195C0
  • Lot Numbers: 217757
  • 222686
  • 224418
  • 225587
  • 227439
  • 228598
  • 230569
  • 234138
  • 235331
  • 236869
  • 238356. 2) Pack Number AMS12195D
  • UDI B098AMS12195D0
  • Lot Numbers: 240974. 3) Pack Number AMS12307
  • UDI B098AMS12307
  • Lot Numbers: 220948
  • 234027
  • 234756
  • 235909

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · endotoxin contamination

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