- Recalling firm
- OBP Medical Corporation
- Reason for recall
- There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
- Affected products (lot / model / serial)
- UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
- Units affected
- 8,224 boxes (148,032 units)
- Distribution pattern
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.
- Firm location
- Lawrence, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2933-2026
- Recall initiated
- July 13, 2026
- FDA classification date
- August 10, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99433
- Last updated on HTM Vibe
- August 26, 2026