OBP Medical ER-Spec vaginal speculums recalled for sharp burr risk
OBP Medical is recalling certain lots of its ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small size, because the plastic blade may have a burr that could create a sharp edge. The edge could contact both the patient and the healthcare provider. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the UDI and lot number on the box against the recall list.
- Stop using affected lots and contact your supplier or healthcare provider about replacements.
- Contact OBP Medical for information on the recall.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 8,224 boxes (148,032 units)
- Illnesses reported
- None reported
- Manufactured in
- 360 Merrimack St Ste 9, Lawrence, MA, United States
- Classification
- Class II
- Recall number
- Z-2933-2026
In the FDA's words
- Description
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1 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. 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. Affected quantity: 8,224 boxes (148,032 units)
- Hazard
- 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.