{"recall":{"id":"fda-device-99300","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls 3 products","firm":"Boston Scientific Corporation","date":"2026-06-30","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.","code":"1. Outer Box UPN: M00513401. Inner Box UPN: M00513400. GTIN: 08714729777960. Lot Number: 38508541. 2. Outer Box UPN: M00513402. Inner Box UPN: M00513400. GTIN: 08714729778028. Lot Numbers: 38517807. 3. Outer Box UPN: M00513411. Inner Box UPN: M00513410. GTIN: 08714729777984. Lot Number: 38488064.","quantity":"5,020 (US); 20,770 (OUS)","number":"Z-2838-2026","classification":"Class II"},{"name":"Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.","code":"1. Outer Box UPN: M00513321; Inner Box UPN: M00513320. GTIN: 08714729648796. Lot Numbers: 38494988. 2. Outer Box UPN: M00513322; Inner Box UPN: M00513320. GTIN: 08714729648802. Lot Numbers: 38497139. 3. Outer Box UPN: M00513331; Inner Box UPN: M00513330. GTIN: 08714729648819. Lot Numbers: 38509777. 4. Outer Box UPN: M00513332; Inner Box UPN: M00513330. GTIN: 08714729648826. Lot Numbers: 38499451. 5. Outer Box UPN: M00513333; Inner Box UPN: M00513330. GTIN: 08714729755494. Lot Number: 38519443.","quantity":"5,020 (US); 20,770 (OUS)","number":"Z-2839-2026","classification":"Class II"},{"name":"Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.","code":"Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.","quantity":"5,020 (US); 20,770 (OUS)","number":"Z-2840-2026","classification":"Class II"}],"reason":"Potential for breach in sterile barrier of device packaging.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,  KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.","nationwide":true,"states":[],"units":"5,020 (US); 20,770 (OUS); 5,020 (US); 20,770 (OUS); 5,020 (US); 20,770 (OUS)","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=99300","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3cd9dd096efe104d","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=99300","record":[{"status":"Ongoing","city":"Marlborough","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99300","recalling_firm":"Boston Scientific Corporation","address_1":"100 Boston Scientific Way","address_2":"","postal_code":"01752-1234","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,  KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.","recall_number":"Z-2838-2026","product_description":"Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:    1. Radial Jaw 4 SC 240cm   Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400.    2.  Radial Jaw 4 SC 240cm   Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400.     3. Radial Jaw 4 SC w/ Needle 240cm   Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.","product_quantity":"5,020 (US); 20,770 (OUS)","reason_for_recall":"Potential for breach in sterile barrier of device packaging.","recall_initiation_date":"20260630","center_classification_date":"20260731","report_date":"20260812","code_info":"1. Outer Box UPN: M00513401. Inner Box UPN: M00513400. GTIN: 08714729777960. Lot Number: 38508541.   2. Outer Box UPN: M00513402. Inner Box UPN: M00513400. GTIN: 08714729778028. Lot Numbers: 38517807.   3. Outer Box UPN: M00513411. Inner Box UPN: M00513410. GTIN: 08714729777984. Lot Number: 38488064.","more_code_info":""},{"status":"Ongoing","city":"Marlborough","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99300","recalling_firm":"Boston Scientific Corporation","address_1":"100 Boston Scientific Way","address_2":"","postal_code":"01752-1234","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,  KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.","recall_number":"Z-2839-2026","product_description":"Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:    1. Radial Jaw 4 LC 240cm   Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320.     2. Radial Jaw 4 LC 240cm   Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320.     3. Radial Jaw 4 LC w/Needle 240cm   Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330.     4. Radial Jaw 4 LC w/Needle 240cm   Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330.    5. Radial Jaw 4 LC w/Needle 240cm   Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.","product_quantity":"5,020 (US); 20,770 (OUS)","reason_for_recall":"Potential for breach in sterile barrier of device packaging.","recall_initiation_date":"20260630","center_classification_date":"20260731","report_date":"20260812","code_info":"1. Outer Box UPN: M00513321; Inner Box UPN: M00513320. GTIN: 08714729648796. Lot Numbers: 38494988.   2. Outer Box UPN: M00513322; Inner Box UPN: M00513320. GTIN: 08714729648802. Lot Numbers: 38497139.   3. Outer Box UPN: M00513331; Inner Box UPN: M00513330. GTIN: 08714729648819. Lot Numbers: 38509777.   4. Outer Box UPN: M00513332; Inner Box UPN: M00513330. GTIN: 08714729648826. Lot Numbers: 38499451.   5. Outer Box UPN: M00513333; Inner Box UPN: M00513330. GTIN: 08714729755494. Lot Number: 38519443.","more_code_info":""},{"status":"Ongoing","city":"Marlborough","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99300","recalling_firm":"Boston Scientific Corporation","address_1":"100 Boston Scientific Way","address_2":"","postal_code":"01752-1234","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,  KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.","recall_number":"Z-2840-2026","product_description":"Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:      Radial Jaw 4 Jumbo 240cm   Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.","product_quantity":"5,020 (US); 20,770 (OUS)","reason_for_recall":"Potential for breach in sterile barrier of device packaging.","recall_initiation_date":"20260630","center_classification_date":"20260731","report_date":"20260812","code_info":"Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.","more_code_info":""}]}}