Recall Z-2933-2026 ยท HIB Speculum, Vaginal, Nonmetal
OBP Medical Corporation
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
| Date | Aug 10, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 commun |
| Quantity | 8,224 boxes (148,032 units) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM Obp Corporation, Sep 9, 2009 |