{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "221356", "product_res_number": "Z-2862-2026", "event_date_initiated": "2026-06-08", "event_date_posted": "2026-08-03", "recall_status": "Open, Classified", "res_event_number": "99340", "product_code": "GCX", "k_numbers": [ "K042454" ], "product_description": "STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600", "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.", "firm_fei_number": "2936485", "recalling_firm": "Stryker Corporation", "address_1": "5900 Optical Ct", "city": "San Jose", "state": "CA", "postal_code": "95138-1400", "additional_info_contact": "Ashley Cupples\n408-754-2000", "reason_for_recall": "There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.", "root_cause_description": "Under Investigation by firm", "action": "Stryker issued an URGENT: Medical Device Recall notice to its consignees on 7/6/2026 via USPS Certified Mail. The notice explained the issue, potential risks, and requested the following: \n\"Actions needed: \n1. Inform individuals within your organization who need to be aware of this action. \n2. Check your internal inventory to locate the affected product using Attachment B. \n3. If affected product is found \n a. Quarantine, stop use and initiate the return process for affected units. \n b. Please complete Business Reply Form or use QR Code on Attachment A. \n4. If affected product is NOT found: \n a. Please complete Business Reply Form or use QR Code on Attachment A. \n5. Maintain awareness of this communication internally until all required actions have been completed within your facility.\" \nFor any additional information or questions please contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.", "product_quantity": "46,212 units", "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.", "openfda": { "k_number": [ "K831116", "K821023", "K924570", "K851384", "K902089", "K920248", "K781988", "K964519", "K931548", "K813029", "K873489", "K884103", "K831939", "K971022", "K895039", "K844882", "K790055", "K972074", "K820765", "K760333", "K910377", "K892549", "K905448", "K924337", "K894695", "K896556", "K870874", "K893649", "K812845", "K890431", "K802440", "K895859", "K822005", "K954726", "K821160", "K910218", "K963648", 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