OBP Medical ER-Spec Vaginal Speculum Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
OBP Medical Corporation is recalling 8,224 boxes of ER-Spec Single-Use Vaginal Speculum with LED Light Source due to a potential burr creating a sharp edge.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
OBP Medical Corporation initiated a voluntary recall after identifying 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.
Which Products Are Affected
The recall affects OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1. A total of 8,224 boxes (148,032 units) are involved. Affected lots include 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, and 25L0802Z with UDI (01)20888937027451. Distribution was nationwide across the United States and to countries including HKG, CAN, NOR, and UAE.
What You Should Do
Consumers and healthcare providers should check for the listed lot numbers and contact the recalling firm for further instructions on returns or refunds.
Why This Matters
The potential sharp edge poses a risk of injury during use of the device.
Source
FDA recall number Z-2933-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,008 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.