{ "columns": [ "city", "classification", "code_info", "country", "distribution_pattern", "event_id", "product_description", "product_quantity", "product_type", "reason_for_recall", "recall_initiation_date", "recall_number", "recalling_firm", "report_date", "source_url", "state" ], "rows": [ { "city": "Waukegan", "classification": "Class II", "code_info": "1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;", "country": "United States", "distribution_pattern": "US Nationwide. Canada.", "event_id": "99380", "product_description": "Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC", "product_quantity": "456 kits", "product_type": "Devices", "reason_for_recall": "Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.", "recall_initiation_date": "20260714", "recall_number": "Z-2943-2026", "recalling_firm": "Cardinal Health 200, LLC", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2943-2026", "state": "IL" }, { "city": "Best", "classification": "Class II", "code_info": "Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690,", "country": "Netherlands", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, M", "event_id": "99378", "product_description": "Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.", "product_quantity": "4,252 units", "product_type": "Devices", "reason_for_recall": "Firmware issue potentially leading to loss of geometry movements.", "recall_initiation_date": "20260629", "recall_number": "Z-2928-2026", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2928-2026", "state": "" }, { "city": "Aliso Viejo", "classification": "Class II", "code_info": "Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)280731(10)0001224137 (01)00842429111062(11)250828(17)280731(10)0001226522 (01)00842429111062(11)250910(17)280831(10)0001264372 (01)00842429111062(11)250911(17)280831(10)0001281308 (01)00842429111062(11)250917(17)280831(10)0001283704 Lot Numbers: 0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704 ", "country": "United States", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.", "event_id": "98909", "product_description": "BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.", "product_quantity": "5500 devices", "product_type": "Devices", "reason_for_recall": "Due to an increase rate of balloon pinhole defects.", "recall_initiation_date": "20260430", "recall_number": "Z-2912-2026", "recalling_firm": "MICROVENTION INC.", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2912-2026", "state": "CA" }, { "city": "Wilmington", "classification": "Class I", "code_info": "Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.", "country": "United States", "distribution_pattern": "Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.", "event_id": "98777", "product_description": "Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.", "product_quantity": "TBD", "product_type": "Devices", "reason_for_recall": "Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.", "recall_initiation_date": "20260706", "recall_number": "Z-2873-2026", "recalling_firm": "Spectra Medical Devices, Llc", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2873-2026", "state": "MA" }, { "city": "Northfield", "classification": "Class II", "code_info": "UDI-DI (each) 00193489015242, UDI-DI (case) 20193489015246, Lot Numbers: All lots produced between 05/27/2025 and 04/10/2026", "country": "United States", "distribution_pattern": "US Nationwide distribution in the states and territories of Guam, Puerto Rico.", "event_id": "99432", "product_description": "Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12\" x 12\", 110 Count Bag, Product Number MSC351450BG4", "product_quantity": "31,728", "product_type": "Devices", "reason_for_recall": "Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.", "recall_initiation_date": "20260630", "recall_number": "Z-2926-2026", "recalling_firm": "Medline Industries, LP", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2926-2026", "state": "IL" }, { "city": "Waukegan", "classification": "Class II", "code_info": "1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case)", "country": "United States", "distribution_pattern": "US Nationwide. Canada.", "event_id": "99380", "product_description": "Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog", "product_quantity": "87182 kits", "product_type": "Devices", "reason_for_recall": "Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.", "recall_initiation_date": "20260714", "recall_number": "Z-2945-2026", "recalling_firm": "Cardinal Health 200, LLC", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2945-2026", "state": "IL" }, { "city": "Flagstaff", "classification": "Class II", "code_info": "Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061,", "country": "United States", "distribution_pattern": "U.S. Nationwide distribution in the states of GA and RI.", "event_id": "99143", "product_description": "GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.", "product_quantity": "13 units", "product_type": "Devices", "reason_for_recall": "10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).", "recall_initiation_date": "20260522", "recall_number": "Z-2914-2026", "recalling_firm": "W L Gore & Associates, Inc.", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2914-2026", "state": "AZ" }, { "city": "Garland", "classification": "Class II", "code_info": "UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232 G22292233 G22292234 G22292235 G22292236 G22292237 G22320238 G22320239 G22320240 G22320241 G22320242 G22320243 G22320244 G22354191 G22362192 G22362194 G22362195 R23083454 G23076104 G23076105 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111", "country": "United States", "distribution_pattern": "US Nationwide distribution in the state of MN.", "event_id": "99369", "product_description": "Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock", "product_quantity": "114,260 kits", "product_type": "Devices", "reason_for_recall": "Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.", "recall_initiation_date": "20260626", "recall_number": "Z-2917-2026", "recalling_firm": "Galt Medical Corporation", "report_date": "20260819", "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2917-2026", "state": "TX" } ] }