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FDA (Device enforcement)Recalled 2026-07-10class ii

Medline Industries, LP: 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 DYNJ

Is my product affected?

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.

  • UPC 10198459385636
  • UPC 40198459385637
  • UPC 10198459539374
  • UPC 40198459539375
  • UPC 10198459255069
  • UPC 40198459255060
  • UPC 10198459419614
  • UPC 40198459419615

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries is recalling 241 surgical convenience kits distributed nationwide across 18 states because they contain a potentially contaminated component that was recalled by the manufacturer. The recalled kits include three product types: LAMI FUSION (SKU CDS982035Y), NON MB MJR NEURO CRANI SM PK (SKU DYNJT6104), and CRANIOTOMY (SKU DYNJ903471I and DYNJ906496K). The affected kits were distributed in Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin.

Consumers can identify affected kits by checking the lot numbers provided in the recall notice. The source document does not specify what remedy or action affected consumers should take regarding these recalled kits.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Kits contain a potentially contaminated component which were recalled by the manufacturer Distribution: 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. Quantity: 241 kits Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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