Agency classClass IIOur severity:High FDA (Devices)·Z-2948-2026·Announced 2026-08-19

Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

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 known defect (endotoxin variability) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits distributed in the United States and Canada. The recall affects various catalog numbers, including PN33NBMYD, PN36NBCH4, PN36NBCH5, PN41ACLA9, and others, across multiple lot numbers.

The reason for the recall is that these procedure kits contain MEDICOM Ritmed Neurological Sponges that were previously recalled due to unexpected variability in endotoxin levels. Endotoxins are substances that can cause adverse reactions in patients when introduced into the body during surgery.

Healthcare facilities and distributors should stop using these specific kits and check their inventory against the provided catalog numbers and lot numbers. Affected units should be returned to Cardinal Health 200, LLC or the original supplier for credit or replacement, in accordance with the company's recall instructions.

The recalled product

Product: Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Kits
Hazard: endotoxin-variability
Affected units: 52,699

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) PN33NBMYD
UDI-DI: 10198956187474(each)
50198956187472(case)
Lot Number: 15463-6
2) PN33NBMYD
3) PN33NBMYD
Lot Number: 14039
4) PN33NBMYD
5) PN33NBMYD
Lot Number: 14813
6) PN33NBMYD
Lot Number: 15192
7) PN33NBMYD
8) PN33NBMYD
9) PN36NBCH4
UDI-DI: 10198956129863(each)
50198956129861(case)
10) PN36NBCH5
UDI-DI: 10198956131538(each)
50198956131536(case)

Distribution

Distributed nationwide across the United States.

Same manufacturer · Cardinal Health 200, LLC

See all →

Severe
Cardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
High
Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07

Same hazard · endotoxin variability