OBP Medical Corporation ER-Spec Vaginal Speculum Recall
There is a potential burr on the proximal plastic blade of the ER-Spec Single-Use Vaginal Speculum with LED Light Source, which may create a sharp edge in contact regions for patients and healthcare providers. The recall covers 8,224 boxes (148,032 units) distributed worldwide, including the U.S. across multiple states. The recall is initiated by FDA and includes lot numbers 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, and 25L0802Z.
| Brand | OBP Medical Corporation |
|---|---|
| Product | OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1 |
| 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. |
| Severity | moderate |
| Units affected | 8224 |
| 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. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any affected ER-Spec Vaginal Speculums.
- Quarantine the product and contact OBP Medical Corporation or the supplier for return, replacement, or refund instructions using the recall details (UDI and lot numbers).
- If you or a patient has been injured, seek medical attention and report the incident to FDA MedWatch.
How to identify the recalled item
| Lot / date codes | UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z |
|---|---|
| Lot / date codes | UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.