{"recall":{"id":"fda-device-99704","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Steris Corporation recalls 6 products","firm":"Steris Corporation","date":"2026-08-31","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006","code":"UDI: 10724995220324 Lot numbers: 260810 - expiration date 08/10/2026 260810A - expiration date 08/10/2026 261106 - expiration date 11/06/2026 270116 - expiration date 01/16/2027","quantity":"266","number":"Z-0070-2027","classification":"Class II"},{"name":"VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007","code":"UDI: 10724995220331 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027","quantity":"409","number":"Z-0071-2027","classification":"Class II"},{"name":"VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060","code":"UDI: 10724995023833 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027","quantity":"1185","number":"Z-0072-2027","classification":"Class II"},{"name":"VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061","code":"UDI: 50724995023824 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027","quantity":"2205","number":"Z-0073-2027","classification":"Class II"},{"name":"VERIFY Biological Steam Test Pack Model/Catalog Number: S3065","code":"UDI: 10724995220300 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027","quantity":"217","number":"Z-0074-2027","classification":"Class II"},{"name":"VERIFY Biological Steam Test Pack Model/Catalog Number: S3069","code":"UDI:10724995023864 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027","quantity":"233","number":"Z-0075-2027","classification":"Class II"}],"reason":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"266; 409; 1185; 2205; 217; 233","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=99704","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"eeb6caf80a07d2a3","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=99704","record":[{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0070-2027","product_description":"VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB006","product_quantity":"266","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI: 10724995220324 Lot numbers: 260810 - expiration date 08/10/2026 260810A - expiration date 08/10/2026 261106 - expiration date 11/06/2026 270116 - expiration date 01/16/2027"},{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0071-2027","product_description":"VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB007","product_quantity":"409","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI: 10724995220331 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027"},{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0072-2027","product_description":"VERIFY Dual Species Self-Contained Biological Indicator    Model/Catalog Number: S3060","product_quantity":"1185","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI: 10724995023833 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027"},{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0073-2027","product_description":"VERIFY Dual Species Self-Contained Biological Indicator  Model/Catalog Number: S3061","product_quantity":"2205","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI: 50724995023824 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027"},{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0074-2027","product_description":"VERIFY Biological Steam Test Pack  Model/Catalog Number: S3065","product_quantity":"217","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI: 10724995220300 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027"},{"status":"Ongoing","city":"Mentor","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99704","recalling_firm":"Steris Corporation","address_1":"5960 Heisley Rd","address_2":"N/A","postal_code":"44060-1834","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0075-2027","product_description":"VERIFY Biological Steam Test Pack  Model/Catalog Number: S3069","product_quantity":"233","reason_for_recall":"Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction","recall_initiation_date":"20260831","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI:10724995023864 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027"}]}}