Home/Recalls/FDA-Z-2933-2026
FDA DevicesClass II

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Published: August 19, 2026Recall ID: Z-2933-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Recalling Firm: OBP Medical Corporation

Reason for Recall / Hazard

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.

Product Description & Identification

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Affected Products

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Additional Source Details

FieldValue
CityLawrence
StateMA
Event id99433
Address 1360 Merrimack St Ste 9
Code infoUDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
Postal code01843-1764
Report date20260819
Product typeDevices
Product quantity8,224 boxes (148,032 units)
Reason for recallThere 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260713
Initial firm notificationLetter
Center classification date20260810

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Overview

  • Recalling FirmOBP Medical Corporation
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - 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.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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