OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
FDA Recall Z-2933-2026 · Posted 2026-08-10
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Recalling FirmOBP Medical Corporation
Recall StatusOpen, Classified
Product CodeHIB
Date Initiated2026-07-13
Product Quantity8,224 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.
Firm Action
On July 14, 2026, OBP Medical a subsidiary of Cooper Surgical issued a Urgent Medical Device Recall Notification to affected consignees via UPS. OBP Medical asked consignees to take the following actions:
1. Physicians/Facilities: Please remove all product of the subject lots from your inventory and note the number of units to be returned on the attached Recall Response Form.
2. Distributors: Please remove all product of the subject lots from your inventory and note the number of units to be returned on the attached Distributor Only Acknowledgement Form. Per the instructions, please communicate this recall notification to all customers that you distributed these devices to.
3. If you are aware of malfunctions or adverse events involving the subject devices which you have not previously reported please report via: Cooper Surgical Customer Complaint Form or FDA's MedWatch Voluntary Form
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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