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.
- Hazard
- endotoxin-contamination
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.
Related recalls
Same category
- HighPermobil M3 Corpus Power Wheelchair Recalled Over Firmware Stability Issue
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05