Z-3029-2026 Class II Ongoing
FDA device recall Z-3029-2026 was initiated by Medline Industries, LP on Jul 10, 2026 and is designated Class II. Reason for recall: Kits contain a potentially contaminated component which were recalled by the manufacturer The recall status is ongoing. Affected quantity: 241 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2026
- Initiation Date
- Jul 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 241 kits
Product Description
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 for Recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
Distribution Pattern
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.
Code Information
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
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3029-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026