Device recall
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Recall number
- Z-2933-2026
- Event id
- 99433
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- OBP Medical Corporation
- Report date
- Aug 19, 2026
- Initiated
- Jul 13, 2026
- Center classification date
- Aug 10, 2026
- Reason
- 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.
- Quantity
- 8,224 boxes (148,032 units)
- Code info
- UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Lawrence, MA, United States