FDA recall, , Moderate risk
OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source
The ER-Spec vaginal speculum may have a burr on the blade, introducing a sharp edge for patients and providers.
Summary by Recall Canary from the FDA notice
What happened
OBP Medical Corporation of Lawrence, Massachusetts, recalled its OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small, because the speculums may 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. The company began the recall on July 13, 2026, and the FDA added it to its Enforcement Report on August 10, 2026.
The recalled product was distributed worldwide, including nationwide in the United States and in the countries of HKG, CAN, NOR, and UAE. The recall involved 8,224 boxes (148,032 units).
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- UDI-DI
- 20888937027451
- Lot code
- 24J1202Z
- 25D2302Z
- 25A0202Z
- 25E1502Z
- 25B2802Z
- 25L0802Z
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and the countries of HKG, CAN, NOR, UAE.
- Company
- OBP Medical CorporationLawrence, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99433
- Recall number
- Z-2933-2026
- Quantity recalled
- 8,224 boxes (148,032 units)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
