{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "222510", "product_res_number": "Z-0154-2027", "event_date_initiated": "2026-09-21", "event_date_posted": "2026-10-14", "recall_status": "Open, Classified", "res_event_number": "99804", "product_code": "FEB", "k_numbers": [ "K082988" ], "product_description": "RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115", "code_info": "UDI: 00724995245658\nLot numbers with expiration dates:\n687046 10/5/2027\n688017 10/19/2027", "firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "Michelle LaVan\n440-2597417", "reason_for_recall": "If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.", "root_cause_description": "Process change control", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 9/8/26 was sent to customers.\n\nUser Action Users can continue using the RAPICIDE product through the remainder of its shelf life. Please immediately inspect your on-hand inventory for product affected by this recall. If bottle bulging is observed, follow the instructions below to release any accumulated pressure and dispose of the product:\n1. Users MUST wear personal protective equipment (PPE) before handling the bottle, including:\na. Safety eyewear\nb. Chemical-resistant gloves\nc. A solvent-resistant apron\nd. Protective footwear appropriate for chemical handling\n2. Move the product to an appropriate, well-ventilated area. Respiratory protection is also recommended in accordance with the RAPICIDE PA Part A Safety Data Sheet (SDS). Refer to Attachment C to this letter for an excerpt of the SDS.\n3. Carefully loosen the cap. Slowly begin untwisting the cap while keeping the threads engaged to allow any accumulated pressure to release gradually.\n4. Allow the pressure to vent. Continue loosening the cap slowly over approximately 1 to 2 minutes until the pressure has been released and the cap can be fully removed.\n5. Dispose of the bottle and contents through your facility's hazardous or special waste program in accordance with applicable local, regional, national, and/or international regulations. Do not replace the cap on a bottle that has exhibited bulging.\n6. Please complete the Recall Response Form included with this letter, and return via email to Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963. Replacement product will be provided for any product that had to be disposed.\nUsers are also reminded to report any adverse events via FDA s MedWatch Database or local competent authority should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please co", "product_quantity": "374 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K172677", "K914442", "K941134", "K162128", "K840208", "K120357", "K830026", "K213833", "K941648", "K040883", "K000216", "K924135", "K243433", "K181472", "K924655", "K201920", "K152189", "K964871", "K933354", "K122172", "K012309", "K181865", "K060458", "K103264", "K061899", "K944776", "K082988", "K924103", "K162120", "K063876", "K230930", "K241168", "K101158", "K850268", "K923672", "K093106", "K921179", "K973558", "K961607", "K190969", "K914145", "K140977", "K944249", "K102996", "K061430", "K923687", "K915402", "K173590", "K820152", "K082392", "K092387", "K915620", "K932930", "K914524", "K954745", "K810818", "K901439", "K261791" ], "device_name": "Accessories, Cleaning, For Endoscope", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "3042172882", "2150060", "1527821", "8021896", "3008157119", "3018094310", "2084725", "3024021261", "9610595", "3003950207", "3005987240", "3005646850", "9610849", "2647580", "3007082252", "3011050570", "3000251274", "8010047", "2518897", "9680353", "1651395", "1220592", "1418479", "1219930", "1222168" ], "fei_number": [ "3042172882", "2150060", "1527821", "3008157119", "3002807795", "3018094310", "3001168737", "3002807391", "3024021261", "3003012447", "2523209", "3003950207", "3004097451", "3005987240", "3005646850", "2647580", "3011050570", "3000251274", "3003662624", "3002964398", "1000080301", "1220592", "1418479", "1219930", "1222168" ] } } ] }