{"recall":{"id":"fda-device-99680","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Atrium Medical Corporation recalls 3 products","firm":"Atrium Medical Corporation","date":"2026-08-07","reported":"2026-09-16","status":"Ongoing","classification":"Class II","products":[{"name":"Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);","code":"1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;","quantity":"3618","number":"Z-3111-2026","classification":"Class II"},{"name":"Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);","code":"1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;","quantity":"2533","number":"Z-3112-2026","classification":"Class II"},{"name":"Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);","code":"1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;","quantity":"256","number":"Z-3113-2026","classification":"Class II"}],"reason":"An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"3618; 2533; 256","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=99680","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f7aa9804ff283f6b","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=99680","record":[{"status":"Ongoing","city":"Merrimack","state":"NH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99680","recalling_firm":"Atrium Medical Corporation","address_1":"40 Continental Blvd","address_2":"","postal_code":"03054-4332","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3111-2026","product_description":"Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;  Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);","product_quantity":"3618","reason_for_recall":"An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.","recall_initiation_date":"20260807","center_classification_date":"20260904","report_date":"20260916","code_info":"1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878;  2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835;  3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681;  4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840;  5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;","more_code_info":""},{"status":"Ongoing","city":"Merrimack","state":"NH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99680","recalling_firm":"Atrium Medical Corporation","address_1":"40 Continental Blvd","address_2":"","postal_code":"03054-4332","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3112-2026","product_description":"Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case;  Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);","product_quantity":"2533","reason_for_recall":"An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.","recall_initiation_date":"20260807","center_classification_date":"20260904","report_date":"20260916","code_info":"1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852;  2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855;  3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859;  4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;","more_code_info":""},{"status":"Ongoing","city":"Merrimack","state":"NH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99680","recalling_firm":"Atrium Medical Corporation","address_1":"40 Continental Blvd","address_2":"","postal_code":"03054-4332","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3113-2026","product_description":"Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;  Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);","product_quantity":"256","reason_for_recall":"An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.","recall_initiation_date":"20260807","center_classification_date":"20260904","report_date":"20260916","code_info":"1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891;  3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;","more_code_info":""}]}}