OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
OBP Medical Corporation · 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 th…
Open FDA's page for this record- Cfres ID
- 221546
- Product res number
- Z-2933-2026
- Event date initiated
- 2026-07-13
- Event date posted
- 2026-08-10
- Recall status
- Open, Classified
- Res event number
- 99433
- Product code
- HIB
- Product description
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
- Code info
- UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
- Firm FEI number
- 3007789561
- Recalling firm
- OBP Medical Corporation
- Address 1
- 360 Merrimack St Ste 9 360 Merrimack St
- Address 2
- Ste 9
- City
- Lawrence
- State
- MA
- Postal code
- 01843-1764
- Root cause description
- Process control
- Product quantity
- 8,224 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.
- 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
- 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.
- K numbers
- K091937
- Harmonized identifiers (openFDA)
- Device name
- Speculum, Vaginal, Nonmetal
- Medical specialty description
- Obstetrics/Gynecology
- Regulation number
- 884.4530
- Device class
- 2
- K number
- K030761, K030693, K050887, K002912, K926536, K991827, K012859, K991963, K822084, K020726, K052420, K951528, K841909, K841867, K822086, K880587, K132668, K903080, K022948, K863275, K000414, K880586, K060129, K894489, K000444, K252208, K012535, K110766, K052912, K973853, K951898, K971979, K984211, K020959, K842014, K863274, K042950, K120743, K052192, K983716 +32 more
- Registration number
- 1316463, 1417592, 3030626857, 3016758972, 2431166, 3004488394, 3006787036, 3004111573, 3005669815, 3032109, 3012944064, 3016159368, 3032747418, 3005515211, 3009308092, 3030733800, 3024374351, 3018762668, 3012551896, 3000682787, 1836161, 3009328501, 3006897996, 3041276591, 3014610488, 3017367014, 3016195240, 3043226252, 2434982, 3016884191, 3031184338, 8030607, 3008902714, 3045323835, 3006410968, 3006538822, 1317202, 3004519921, 3015416207, 3037918935 +79 more
- FEI number
- 1316463, 1417592, 3030626857, 3016758972, 3004488394, 3006787036, 3004111573, 3005669815, 3012944064, 3016159368, 3032747418, 3005515211, 3009308092, 3004525092, 3030733800, 3024374351, 3018762668, 1000123297, 3012551896, 3000682787, 3009328501, 3006509795, 1000137528, 3006897996, 3041276591, 1000112877, 3014610488, 3017367014, 3016195240, 3043226252, 2434982, 3016884191, 1000512168, 3005846326, 3031184338, 3008902714, 3045323835, 3006410968, 3006538822, 3003154916 +79 more