- Recalling firm
- Medline Industries, LP
- Reason for recall
- Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- Affected products (lot / model / serial)
- SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
- Units affected
- 113,843 kits
- Distribution pattern
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2589-2026
- Recall initiated
- February 27, 2026
- FDA classification date
- June 25, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 99062
- Last updated on HTM Vibe
- July 24, 2026