OBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges
OBP Medical is recalling ER-Spec Single-Use Vaginal Speculums because a burr on the plastic blade may create a sharp edge, posing a risk of injury to patients and providers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sharp edge causing injury) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
OBP Medical Corporation is recalling 8,224 boxes (148,032 units) of ER-Spec Single-Use Vaginal Speculums with LED Light Source, X-Small (REF: C020130-1). The recall affects specific lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, and 25L0802Z. The products were distributed worldwide, including nationwide in the United States and in the countries of HKG, CAN, NOR, and UAE.
The recall was initiated because there is a potential for the vaginal speculums to contain a burr on the proximal plastic blade. This defect may introduce a sharp edge in the contact regions, which could pose a risk of injury to both the patient and the healthcare provider during use.
Healthcare facilities and consumers should stop using the affected speculums immediately. Users should check the lot numbers on their inventory against the list provided in this notice. If the lot numbers match, the products should be quarantined and returned to OBP Medical Corporation for credit or replacement, in accordance with the company's recall instructions.
The recalled product
- Product
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Manufacturer
- OBP Medical Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI: (01)20888937027451/ Lots: 24J1202Z
- 25D2302Z
- 25A0202Z
- 25E1502Z
- 25B2802Z
- 25L0802Z
Distribution
Related recalls
Same hazard · sharp edge
See all →- HighMRI Machine Coil Seal Adhesive May Create Sharp Edges
FDA (Devices) · 2024-02-07
- SevereMedline Nurse Training Kits Recalled for Sharp Tracheostomy Brush
FDA (Devices) · 2024-01-03
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03
- SevereMedline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect
FDA (Devices) · 2024-01-03
- HighTarget Recalls Decorative Mailbox Due to Laceration Hazard
CPSC · 2021-12-10
Similar recalls
- SevereCustomed Recalls OB Packs Due to Potential Packaging Integrity Compromise
FDA (Devices) · 2014-09-10
- ModerateCooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging
FDA (Devices) · 2015-07-01
- HighArgon Medical Devices Recalls Vascuclamp Vascular Clamps Due to Sterility Risk
FDA (Devices) · 2019-11-13
- CriticalCustomed Recalls O.B. Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- ModerateStryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
FDA (Devices) · 2018-09-05
- SevereCustomed O.B. Pack Recall Due to Sterility Compromise
FDA (Devices) · 2014-12-10