Agency classClass IIOur severity:High FDA (Devices)·Z-2990-2026·Announced 2026-08-26

Medicom Recalls Neurological Sponges Due to Endotoxin Variability

Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a potential for unexpected variability in endotoxin levels, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile, Models 55992C to 55998C. The recall was initiated due to a potential for unexpected variability of endotoxin levels on the products.

The source text does not specify the number of units affected, the distribution scope, or the specific lot numbers involved in this recall. No illnesses or injuries have been reported in the provided text.

Consumers and healthcare facilities should check their inventory for the affected models and stop using them if they match the recalled description. They should contact Medicom for further instructions on how to return or dispose of the products.

The recalled product

Product: American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
Manufacturer: American Contract Systems Inc
Category: Medical Device — Surgical Sponges
Hazard: endotoxin-variability
Affected units: 160

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 (13)

Model/Item Number MHAC65AH
UDI/DI 191072211910
Lot Number 42-8606211
Lot Number 42-8687611
Lot Number 42-8847511
Model/Item Number MHSP99AF
UDI/DI 191072214782
Lot Number 42-8423411
Lot Number 42-8470411
Lot Number 42-8527611
Lot Number 42-8601311
Lot Number 42-8731511
Lot Number 42-8795311.

Distribution

Distributed in 3 states:

Same manufacturer · American Contract Systems Inc

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Same hazard · endotoxin variability