Recall Z-2933-2026— OBP Medical Corporation

Name: FDA recall Z-2933-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Class II · Ongoing

Class II FDA medical device recall by OBP Medical Corporation, initiated 2026-07-13. It names one FDA 510(k) clearance: K091937. 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..

Recalling firm: OBP Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-07-13
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation·cleared 2009-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.