Z-3027-2026 Class II Ongoing
FDA device recall Z-3027-2026 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: 169 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2026
- Initiation Date
- Jul 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 kits
Product Description
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.
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 CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25LBR956; Medline Kit SKU CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25KBP729; Medline Kit SKU CDS982654L, UDI/DI 10195327306830 (each) 40195327306831 (case), Lot Number 26EBN087; Medline Kit SKU CDS982662Q, UDI/DI 10195327306793 (each) 40195327306794 (case), Lot Number 25JBK543; Medline Kit SKU DYNJ54382F, UDI/DI 10198459794285 (each) 40198459794286 (case), Lot Number 26FMC227; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMK551; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMB880.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3027-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026