FDA Medical Device Recalls (openFDA)
OBP Medical Corporation: OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Recall number
- Z-2933-2026
- Recalling firm
- OBP Medical Corporation
- Product
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Status
- Open, Classified
- Initiated
- 2026-07-13
- Posted
- 2026-08-10
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
- 510(k) numbers
- ["K091937"]
- PMA numbers
- not on file
- Product code
- HIB
- Firm FEI
- 3007789561
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28