{"recall":{"id":"fda-device-99433","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"OBP Medical Corporation recalls OBP Medical ","firm":"OBP Medical Corporation","date":"2026-07-13","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1","code":"UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z","quantity":"8,224 boxes (148,032 units)","number":"Z-2933-2026","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, \tIA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, \tOR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.","nationwide":true,"states":[],"units":"8,224 boxes (148,032 units)","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99433","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"07127f4686841bcc","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99433","record":[{"status":"Ongoing","city":"Lawrence","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99433","recalling_firm":"OBP Medical Corporation","address_1":"360 Merrimack St Ste 9","address_2":"","postal_code":"01843-1764","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, \tIA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, \tOR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.","recall_number":"Z-2933-2026","product_description":"OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small  REF: C020130-1","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.","recall_initiation_date":"20260713","center_classification_date":"20260810","report_date":"20260819","code_info":"UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z","more_code_info":""}]}}