{"recall":{"id":"fda-device-99340","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Stryker Corporation recalls 5 products","firm":"Stryker Corporation","date":"2026-06-08","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600","code":"GTIN 07613327061499, Batch Numbers: 24262FG2, 24263FG2, 24264FG2, 24266FG2, 24267FG2, 24268FG2, 24269FG2, 24283FG2, 24284FG2, 24286FG2, 24287FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24293FG2, 24294FG2, 24295FG2, 24296FG2, 24298FG2, 24299FG2, 24302FG2, 24303FG2, 24304FG2, 24305FG2, 24306FG2, 24309FG2, 24311FG2, 24312FG2, 24316FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24321FG2, 24322FG2, 24323FG2, 24324FG2, 24325FG2, 24326FG2, 24337FG2, 24339FG2, 24346FG2, 24347FG2, 24348FG2, 24349FG2, 24350FG2, 24351FG2, 24352FG2, 24353FG2, 24354FG2, 24355FG2, 24356FG2, 24358FG2, 24361FG2, 25007FG2, 25008FG2, 25009FG2, 25010FG2, 25013FG2, 25014FG2, 25017FG2, 25020FG2, 25027FG2, 25028FG2, 25029FG2, 25035FG2, 25036FG2, 25037FG2, 25038FG2, 25041FG2, 25043FG2, 25044FG2, 25045FG2, 25048FG2, 25052FG2, 25055FG2, 25056FG2, 25057FG2, 25058FG2, 25059FG2, 25062FG2, 25063FG2, 25064FG2, 25065FG2, 25069FG2, 25070FG2, 25071FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25084FG2, 25085FG2, 25086FG2, 25087FG2, 25092FG2, 25093FG2, 25094FG2, 25097FG2, 25098FG2, 25099FG2, 25100FG2, 25101FG2, 25107FG2, 25112FG2, 25113FG2, 25114FG2, 25115FG2, 25118FG2, 25119FG2, 25120FG2, 25121FG2, 25122FG2, 25125FG2, 25126FG2, 25134FG2, 25135FG2, 25137FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25144FG2, 25148FG2, 25155FG2, 25160FG2, 25161FG2, 25162FG2, 25163FG2.","quantity":"46,212 units","number":"Z-2862-2026","classification":"Class II"},{"name":"STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620","code":"GTIN 07613327061659, Batch Numbers: 24263FG2, 24264FG2, 24265FG2, 24267FG2, 24269FG2, 24270FG2, 24271FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24296FG2, 24297FG2, 24298FG2, 24304FG2, 24306FG2, 24313FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24327FG2, 24340FG2, 24341FG2, 24342FG2, 24343FG2, 24344FG2, 24345FG2, 24347FG2, 24348FG2, 24356FG2, 24357FG2, 24358FG2, 24361FG2, 25007FG2, 25010FG2, 25011FG2, 25015FG2, 25016FG2, 25017FG2, 25020FG2, 25021FG2, 25022FG2, 25023FG2, 25024FG2, 25027FG2, 25028FG2, 25030FG2, 25037FG2, 25038FG2, 25041FG2, 25042FG2, 25043FG2, 25049FG2, 25050FG2, 25051FG2, 25055FG2, 25065FG2, 25066FG2, 25069FG2, 25070FG2, 25071FG2, 25072FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25083FG2, 25084FG2, 25085FG2, 25086FG2, 25090FG2, 25091FG2, 25092FG2, 25093FG2, 25097FG2, 25098FG2, 25098GF2, 25099FG2, 25100FG2, 25104FG2, 25105FG2, 25106FG2, 25111FG2, 25112FG2, 25127FG2, 25128FG2, 25129FG2, 25132FG2, 25133FG2, 25134FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25143FG2, 25147FG2, 25148FG2, 25149FG2, 25150FG2, 25151FG2, 25153FG2, 25154FG2, 25155FG2, 25156FG2, 25157FG2.","quantity":"41,052 units","number":"Z-2863-2026","classification":"Class II"},{"name":"STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640","code":"GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.","quantity":"2,739 of units","number":"Z-2864-2026","classification":"Class II"},{"name":"STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530","code":"GTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.","quantity":"11,857 Units","number":"Z-2865-2026","classification":"Class II"},{"name":"STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540","code":"GTIN 0761332706146, Batch Numbers: 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.","quantity":"589 Units","number":"Z-2866-2026","classification":"Class II"}],"reason":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","nationwide":true,"states":[],"units":"46,212 units; 41,052 units; 2,739 of units; 11,857 Units; 589 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=99340","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e35e485e26544c3f","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=99340","record":[{"status":"Ongoing","city":"San Jose","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99340","recalling_firm":"Stryker Corporation","address_1":"5900 Optical Ct","address_2":"","postal_code":"95138-1400","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","recall_number":"Z-2862-2026","product_description":"STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600","product_quantity":"46,212 units","reason_for_recall":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","recall_initiation_date":"20260608","center_classification_date":"20260803","report_date":"20260812","code_info":"GTIN 07613327061499, Batch Numbers:   24262FG2, 24263FG2, 24264FG2, 24266FG2, 24267FG2, 24268FG2, 24269FG2, 24283FG2, 24284FG2, 24286FG2, 24287FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24293FG2, 24294FG2, 24295FG2, 24296FG2, 24298FG2, 24299FG2, 24302FG2, 24303FG2, 24304FG2, 24305FG2, 24306FG2, 24309FG2, 24311FG2, 24312FG2, 24316FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24321FG2, 24322FG2, 24323FG2, 24324FG2, 24325FG2, 24326FG2, 24337FG2, 24339FG2, 24346FG2, 24347FG2, 24348FG2, 24349FG2, 24350FG2, 24351FG2, 24352FG2, 24353FG2, 24354FG2, 24355FG2, 24356FG2, 24358FG2, 24361FG2, 25007FG2, 25008FG2, 25009FG2, 25010FG2, 25013FG2, 25014FG2, 25017FG2, 25020FG2, 25027FG2, 25028FG2, 25029FG2, 25035FG2, 25036FG2, 25037FG2, 25038FG2, 25041FG2, 25043FG2, 25044FG2, 25045FG2, 25048FG2, 25052FG2, 25055FG2, 25056FG2, 25057FG2, 25058FG2, 25059FG2, 25062FG2, 25063FG2, 25064FG2, 25065FG2, 25069FG2, 25070FG2, 25071FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25084FG2, 25085FG2, 25086FG2, 25087FG2, 25092FG2, 25093FG2, 25094FG2, 25097FG2, 25098FG2, 25099FG2, 25100FG2, 25101FG2, 25107FG2, 25112FG2, 25113FG2, 25114FG2, 25115FG2, 25118FG2, 25119FG2, 25120FG2, 25121FG2, 25122FG2, 25125FG2, 25126FG2, 25134FG2, 25135FG2, 25137FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25144FG2, 25148FG2, 25155FG2, 25160FG2, 25161FG2, 25162FG2, 25163FG2.","more_code_info":""},{"status":"Ongoing","city":"San Jose","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99340","recalling_firm":"Stryker Corporation","address_1":"5900 Optical Ct","address_2":"","postal_code":"95138-1400","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","recall_number":"Z-2863-2026","product_description":"STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620","product_quantity":"41,052 units","reason_for_recall":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","recall_initiation_date":"20260608","center_classification_date":"20260803","report_date":"20260812","code_info":"GTIN 07613327061659, Batch Numbers:  24263FG2, 24264FG2, 24265FG2, 24267FG2, 24269FG2, 24270FG2, 24271FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24296FG2, 24297FG2, 24298FG2, 24304FG2, 24306FG2, 24313FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24327FG2, 24340FG2, 24341FG2, 24342FG2, 24343FG2, 24344FG2, 24345FG2, 24347FG2, 24348FG2, 24356FG2, 24357FG2, 24358FG2, 24361FG2, 25007FG2, 25010FG2, 25011FG2, 25015FG2, 25016FG2, 25017FG2, 25020FG2, 25021FG2, 25022FG2, 25023FG2, 25024FG2, 25027FG2, 25028FG2, 25030FG2, 25037FG2, 25038FG2, 25041FG2, 25042FG2, 25043FG2, 25049FG2, 25050FG2, 25051FG2, 25055FG2, 25065FG2, 25066FG2, 25069FG2, 25070FG2, 25071FG2, 25072FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25083FG2, 25084FG2, 25085FG2, 25086FG2, 25090FG2, 25091FG2, 25092FG2, 25093FG2, 25097FG2, 25098FG2, 25098GF2, 25099FG2, 25100FG2, 25104FG2, 25105FG2, 25106FG2, 25111FG2, 25112FG2, 25127FG2, 25128FG2, 25129FG2, 25132FG2, 25133FG2, 25134FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25143FG2, 25147FG2, 25148FG2, 25149FG2, 25150FG2, 25151FG2, 25153FG2, 25154FG2, 25155FG2, 25156FG2, 25157FG2.","more_code_info":""},{"status":"Ongoing","city":"San Jose","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99340","recalling_firm":"Stryker Corporation","address_1":"5900 Optical Ct","address_2":"","postal_code":"95138-1400","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","recall_number":"Z-2864-2026","product_description":"STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640","product_quantity":"2,739 of units","reason_for_recall":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","recall_initiation_date":"20260608","center_classification_date":"20260803","report_date":"20260812","code_info":"GTIN 07613327061475, Batch Number:  24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.","more_code_info":""},{"status":"Ongoing","city":"San Jose","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99340","recalling_firm":"Stryker Corporation","address_1":"5900 Optical Ct","address_2":"","postal_code":"95138-1400","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","recall_number":"Z-2865-2026","product_description":"STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530","product_quantity":"11,857 Units","reason_for_recall":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","recall_initiation_date":"20260608","center_classification_date":"20260803","report_date":"20260812","code_info":"GTIN 07613327061352, Batch Numbers  24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.","more_code_info":""},{"status":"Ongoing","city":"San Jose","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99340","recalling_firm":"Stryker Corporation","address_1":"5900 Optical Ct","address_2":"","postal_code":"95138-1400","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","recall_number":"Z-2866-2026","product_description":"STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540","product_quantity":"589 Units","reason_for_recall":"There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.","recall_initiation_date":"20260608","center_classification_date":"20260803","report_date":"20260812","code_info":"GTIN 0761332706146, Batch Numbers:  24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.","more_code_info":""}]}}