The Recall Desk
HighFDA (Devices)·Z-1130-2025·Announced 2025-02-19

Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

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: FDA classified this as Class II. No illnesses, injuries, or deaths have been reported. However, endotoxin contamination in non-sterile surgical materials represents a risk-of-harm scenario with potential for patient harm, meeting the High (3) severity criteria.

Plain-English summary

Cardinal Health 200, LLC is recalling Presource maxillofacial surgical kits due to potential endotoxin contamination in the non-sterile surgical strips and patties. The recall involves 973,785 total units across 21 different catalog numbers and 35 lot numbers.

Endotoxins are bacterial contaminants that may be present in non-sterile materials. Their presence in surgical products intended for maxillofacial procedures represents a potential health concern, as surgical use can introduce such contaminants into the body.

The affected products were distributed worldwide to the United States, Canada, and Saudi Arabia. Affected catalog numbers include PWV2MF104, PWV2MF105, PWV2MF106, PWV2MF107, PWV2MF108, PWV2MF109, PWV2MF10V, PWV2MF10W, PWV2MF10Y, PWV2MF10Z, PWV2MF111, PWV2MF112, PWV2MFCP2, PWV2MFCP3, PWV2MFCP4, PWV2MFCPA, PWV2MFCPB, PWV2MFCPC, PWV2MFCPD, PWV2MFCPE, and PWV2MFCPF with corresponding lot numbers identified in the official notice.

Healthcare facilities should immediately quarantine affected products by catalog number and lot number, discontinue use, and contact Cardinal Health for instructions on product return and replacement.

The recalled product

Product
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Kits
Hazard
Affected units
973,785

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) PWV2MF104
  • UDI-DI:10888439676167 (each) 50888439676165 (case)
  • Lot Number: J46C10
  • 2) PWV2MF105
  • UDI-DI:10195594004217 (each) 50195594004215 (case)
  • Lot Number: J8998R
  • 3) PWV2MF106
  • UDI-DI:10195594095994 (each) 50195594095992 (case)
  • Lot Number: 5136000
  • 4) PWV2MF107
  • UDI-DI:10195594148065 (each) 50195594148063 (case)
  • Lot Number: 5140389
  • 5) PWV2MF108
  • UDI-DI:10195594228941 (each) 50195594228949 (case)
  • 6) PWV2MF109
  • UDI-DI:10195594394875 (each) 50195594394873 (case)
  • Lot Number: J65K18
  • 7) PWV2MF10V
  • UDI-DI:10888439342741 (each) 50888439342749 (case)
  • Lot Number: HP1027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Cardinal Health 200, LLC 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 12 products in this recall →

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