A burr left on the edge of an ear loop — 20 device records concern a moulding artefact (148,032 surgical masks)
In a single-use vaginal speculum with an LED light source, a burr may remain on the proximal plastic blade. The burr can form a sharp edge in the regions contacted by both the patient and the healthcare provider. The recall covers 8,224 boxes, or 148,032 units, distributed in the United States and to Hong Kong, Canada, Norway and the United Arab Emirates.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmOBP Medical Corporation
- ReasonThere 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.
- DistributionWorldwide - 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,...
- Recall initiated2026-07-13
Key points
- The product is the ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small, REF C020130-1 — 8,224 boxes, or 148,032 units.
- A burr may remain on the proximal plastic blade, introducing a sharp edge in the regions contacted by both the patient and the healthcare provider.
- Because the device is single use, it lacks the cleaning and inspection stages at which a forming defect might be noticed on a reusable instrument.
- Distribution covers 42 US states plus Hong Kong, Canada, Norway and the United Arab Emirates.
- Of the 779 device recalls this site holds as of 2026-08-28, 281 — 36 percent — record distribution that includes worldwide.
- Of the 779 device records this site holds as of 2026-09-01, 20 name a burr in the reason.
1A burr is what manufacturing leaves behind
A burr is the ridge of material left along an edge when plastic or metal is formed and not fully trimmed away. In industrial products it is unremarkable; on an instrument that touches the body it means something else. What is at issue here is the proximal plastic blade, and the record states explicitly that this is a region contacted by both the patient and the healthcare provider. The person using the instrument and the person it is used on can meet the same edge.
2What the single-use premise entails
This product is single use: it is used once and discarded. An instrument that is cleaned and sterilized for repeated use passes through human hands at those stages, which inserts an opportunity to notice a forming defect. A disposable instrument has no such opportunity. It is designed to be taken from its packaging and applied to the body, so the quality at the moment of manufacture arrives on the floor unchanged. The larger the volume distributed, the more that premise weighs.
336 percent of device recalls carry a worldwide record
Of the 1,408 FDA recall records this site holds as of 2026-08-28, 779 concern medical devices, and 281 of those — 36 percent — record distribution that includes worldwide. This case reached 42 US states plus Hong Kong, Canada, Norway and the United Arab Emirates. US recall records do not stay inside the United States, because device distribution already crosses borders, which is part of why this site covers the area.
How often the burr occurred, and whether any injury resulted, are not part of this record.
4Twenty device records concern a moulding artefact
Of the 779 device records this site holds as of 2026-09-01, 20 name a burr in the reason for recall.
A burr is the surplus ridge left at an edge when plastic or metal is formed in a mould. It does not impair the function, which makes it easy to pass over, yet on a product that touches skin it becomes a source of abrasion and discomfort. On a disposable consumed in bulk, as here, the effect per unit is small and the number of people reached decides the weight.
Why it matters
Single-use instruments have no stage at which human eyes and hands pass over them just before use, so quality at the moment of manufacture connects directly to safety on the floor, and volume widens the reach. A US recall reaching several countries is unremarkable, and the response has to cross borders with it.
FAQ
What is a burr?
Why does single use make this harder?
Did any injury occur?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2933-2026