- 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)
- UDI/DI 10198459312557 (each) 40198459312558 (case), Lot Number 25LLA853
- Units affected
- 24 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-3021-2026
- 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