{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "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", "k_numbers": [ "K091937" ], "product_description": "OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small\nREF: 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", "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.", "root_cause_description": "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:\n\n1. 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.\n\n2. 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.\n\n3. 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", "product_quantity": "8,224 boxes (148,032 units)", "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.", "openfda": { "k_number": [ "K935636", "K120743", "K841867", "K132668", "K110766", "K922154", "K880588", "K052912", "K000414", "K894489", "K021017", "K880586", "K984211", "K842014", "K880587", "K040817", "K983716", "K092870", "K003540", "K973853", "K926536", "K070964", "K000444", "K920803", "K030693", "K052420", "K133857", "K974228", "K013835", "K963377", "K130046", "K941272", "K951898", "K030761", "K050887", "K822086", "K022948", "K020959", "K012859", "K020726", "K822084", "K882605", "K933521", "K252208", "K991963", "K830725", "K863274", "K052314", "K072942", "K060129", "K021849", "K021676", "K903080", "K925501", "K894957", "K041757", "K052192", "K072762", "K930954", "K013817", "K012535", "K991827", "K002912", "K992736", "K091937", "K951528", "K863275", "K841909", "K971979", "K042950", "K061339", "K903744" ], "registration_number": [ "2027062", "3013298431", "3009771213", "3016884033", "3008902714", "3003965134", "3015142721", "3019315696", "3010419931", "3004488394", "3012303525", "3010830834", "1319639", "3018503755", "3004111573", "3006591312", "3015134755", "3030626857", "3016758972", "3009104075", "3013530901", "3013557562", "3001124136", "3034629649", "9616088", "3004941127", "3041276591", "8043235", "3008496560", "3019387954", "3012421607", "3015058854", "3014579161", "3022120070", "3038772401", "2435946", "3010155661", "3016904853", "3012494290", "3043226252", "3000682787", "8030607", "3015416207", "3018762668", "1043214", "3045058049", "1055236", "3005669815", "9680222", "3012944064", "3014902417", "3006410968", "3014610488", "1317202", "3004530184", "1319480", "3009308092", "3018779125", "3006897996", "3005739529", "3030447506", "9613910", "3006538822", "3004472854", "3033536319", "1423537", "2431166", "1216677", "3030733800", "3016250458", "1123010", "3014437893", "1316463", "3017367014", "3011669217", "1450908", "3016884191", "1018470", "3003431869", "3038285060", "3015276780", "3012292909", "3004519921", "1417592", "3045323835", "2648727", "3032109", "3014421917", "8044093", "3015173212", "3031184338", "3016159368", "1054241", "3024374351", "2320762", "1836161", "3006787036", "1061124", "3000268902", "3015895045", "3006087789", "1315756", "3005515211", "3003528228", "3014637079", "3006673317", "1835058", "3011689956", "3009328501", "3016195240", "3032747418", "3012551896", "3009255580", "3005273623", "2434982", "3013517171", "3034669683", "3037918935" ], "fei_number": [ "2027062", "1000112968", "3013298431", "3009771213", "3016884033", "3008902714", "3003965134", "3015142721", "3019315696", "1000123297", "3010419931", "3003040625", "3004488394", "3012303525", "3018503755", "3005729015", "2523865", "3004111573", "3006591312", "3015134755", "3030626857", "3016758972", "3009104075", "3002750084", "3013530901", "3013557562", "3001124136", "3034629649", "1000138054", "3004941127", "3041276591", "3008496560", "3019387954", "3012421607", "3005596530", "3015058854", "3014579161", "3022120070", "3038772401", "1000512168", "3002902735", "3010155661", "3016904853", "3012494290", "3043226252", "3000682787", "1043214", "3015416207", "3018762668", "3045058049", "3005669815", "1000517814", "3012944064", "3001236905", "3014902417", "3006410968", "3014610488", "1317202", "3004530184", "3006897996", "3009308092", "3018779125", "3005739529", "3030447506", "3004574120", "3006538822", "3004472854", "3033536319", "1216677", "3030733800", "3016250458", "3006509795", "3003154916", "3014437893", "1316463", "3017367014", "3011669217", "1450908", "3016884191", "1018470", "3003431869", "3038285060", "3015276780", "3012292909", "1417592", "3045323835", "3005846326", "1000137528", "2648727", "3014421917", "3015173212", "3031184338", "3016159368", "2981", "3004525092", "3024374351", "3001238683", "1000120295", "3006787036", "3000268902", "3015895045", "3006087789", "1315756", "3005515211", "3003528228", "3014637079", "3011689956", "3009328501", "3016195240", "3032747418", "3012551896", "3009255580", "3005273623", "2434982", "1000112877", "3013517171", "3034669683", "3037918935" ], "device_name": "Speculum, Vaginal, Nonmetal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4530", "device_class": "2" } } ] }