Agency classClass IIOur severity:High FDA (Devices)·Z-2989-2026·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 endotoxin variability, 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 through 55998C. The recall was initiated because of the 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 states where these products were sold. No illnesses or injuries have been reported in the provided text.

Healthcare facilities and consumers should check their inventory for the affected model numbers and lot numbers. If you have these products, contact the manufacturer or your medical device supplier for instructions on how to proceed.

The recalled product

Product: American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number…
Manufacturer: American Contract Systems Inc
Category: Medical Device — Surgical Sponges
Hazard: endotoxin-variability
Affected units: 4,789

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)

Model/Item Number UDCP57AI
UDI/DI 191072216250
Lot Number 42-8388111
Lot Number 42-8474311
Lot Number 42-8521711
Lot Number 42-8547611
Lot Number 42-8672411
Lot Number 42-8775211
Lot Number 42-8810511
Model/Item Number HSLM53AC
UDI/DI 191072238207
Lot Number 42-8447111
Lot Number 42-8548311
Lot Number 42-8630311
Lot Number 42-8785011
Lot Number 42-8742911
Model/Item Number MHCP75AH
UDI/DI 191072211934
Lot Number 42-8455911
Lot Number 42-8498111

Distribution

Distributed in 3 states:

Same manufacturer · American Contract Systems Inc

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Same hazard · endotoxin variability