- Recalling firm
- Medline Industries, LP
- Reason for recall
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Affected products (lot / model / serial)
- 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.
- Units affected
- 241 kits
- 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.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3029-2026
- Recall initiated
- July 10, 2026
- FDA classification date
- August 26, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99507
- Last updated on HTM Vibe
- September 8, 2026