CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

Cardinal Health Presource Kits: Kit,Neuro Lami,MD Anderson recalled

Cardinal Health 200 is recalling Cardinal Health Presource Kits: Kit,Neuro Lami,MD Anderson, distributed nationwide in the US. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J79Z55 ; 3) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220A ; 4) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220D ; 5) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J4953F ; 6) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J46C13 ;
Quantity recalled973,785 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1127-2025
FDA event ID
95947
Recalling firm
Cardinal Health 200, Waukegan, IL
Classification
Class II
Status
Ongoing
Recall initiated
8 Nov 2024
FDA classified
10 Feb 2025
Reported
19 Feb 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

8 Nov 2024Recall initiated by company
10 Feb 2025Classified by FDA+94 days
19 Feb 2025Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Nationwide

Questions about this recall

Why was it recalled?

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Which lots are affected?

1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J79Z55 ; 3) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220A ; 4) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220D ; 5) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J4953F ; 6) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J46C13 ;

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 95947

This product is part of a recall event; the main page for the event is Cardinal Health Presource Kits: Urology Robotic Pack recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IICardinal Health Presource Kits: Urology Robotic Pack recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Laryngoscopy Pack recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Kit,Robotic Hysterectomy recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Kit, Carotid Endarterectomy recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Kit,Maxillofacial,Presbyterian recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Acdf Pack recalledCardinal Health 200SterilityNationwide
CLASS IICardinal Health Presource Kits: Ophthalmology Endo Dcr Xtrs PK recalledCardinal Health 200SterilityNationwide

More recalls from Cardinal Health 200

All 290
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPresource Packs containing Medtronic Microstream Components recalledCardinal Health 200Device MalfunctionIL
DeviceCLASS IIPresource Packs Containing Stryker StrykeFlow PS recalledCardinal Health 200Packaging DefectsNationwide
DeviceCLASS IIPresource Packs Containing Stryker StrykeFlow PS recalledCardinal Health 200Packaging DefectsNationwide
DeviceCLASS IIPresource Packs Containing Stryker StrykeFlow PS recalledCardinal Health 200Packaging DefectsNationwide
DeviceCLASS IIPresource Packs Containing Stryker StrykeFlow PS recalledCardinal Health 200Packaging DefectsNationwide

Other Other Medical Devices recalls

All 13,908
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPlastics Tray kits recalled by Avid MedicalAvid MedicalForeign MaterialNationwide
DeviceCLASS IIHeart Prep Tray kits recalled by Avid MedicalAvid MedicalOtherNationwide
DeviceCLASS IIPack Open Heart Cfh kits recalled by Avid MedicalAvid MedicalOtherNationwide
DeviceCLASS IISperm Ab Elisa (96 well plate test) recalled by DRG InternationalDRG InternationalOtherNationwide
DeviceCLASS IIIBeneView Series recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide