- Recalling firm
- ASP Global, LLC.
- Reason for recall
- Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
- Affected products (lot / model / serial)
- Lot Code: Model Number: 564011 UDI-DI: (01) 00885914044612 All Lots produced from 01SEP2016 to 01MAR2023: S0823STY, S0922STY, S1101STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0730STY, M0930STY, M1230STY
- Units affected
- 15770
- Distribution pattern
- US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.
- Firm location
- Austell, GA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0013-2027
- Recall initiated
- August 24, 2026
- FDA classification date
- October 1, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99676
- Last updated on HTM Vibe
- October 13, 2026