Recall Ledger

Medline convenience kits labeled as: 1) LAMI FUSION recall (Medline Industries, LP)

Medical deviceClass IIOngoing

Summary: Medline Industries, LP is recalling Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.. Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer.

What is being recalled

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.

Why

Kits contain a potentially contaminated component which were recalled by the manufacturer

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI. (states named: Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, Wisconsin)

How to tell if yours is affected

Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25JML577; Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDB085; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDA481; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26CDA102; Medline Kit SKU DYNJ906496K, UDI/DI 10198459419614 (each) 40198459419615 (case), Lot Number 25KLA074.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3029-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 10, 2026
ReportedSeptember 2, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity241 kits

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