OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Summary
The FDA issued a Class II for OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small by OBP Medical Corporation. 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 fo.
Details
Source
Device Recall
External ID
Z-2933-2026
Action Date
2026-08-19
Status
Ongoing
Category
device
Product Description
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Lot/Code Info: UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
Quantity Affected: 8,224 boxes (148,032 units)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Lawrence, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OBP Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OBP Medical Corporation have FDA actions?
This is the only FDA action we have on record for OBP Medical Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2933-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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