{"recall":{"id":"fda-device-99301","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls 9 products","firm":"Medline Industries, LP","date":"2026-06-08","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I","code":"DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710","quantity":"980 kits","number":"Z-2779-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M","code":"DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622","quantity":"980 kits","number":"Z-2780-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U","code":"DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068","quantity":"980 kits","number":"Z-2781-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105","code":"DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203","quantity":"980 kits","number":"Z-2782-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B","code":"DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889","quantity":"980 kits","number":"Z-2783-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M","code":"CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761","quantity":"980 kits","number":"Z-2784-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F","code":"DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670","quantity":"980 kits","number":"Z-2785-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J","code":"DYNJ61206J UDI-DI 10198459488597 Lots 25IMF461 25LMG907","quantity":"980 kits","number":"Z-2786-2026","classification":"Class II"},{"name":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G","code":"DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601","quantity":"980 kits","number":"Z-2787-2026","classification":"Class II"}],"reason":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","nationwide":true,"states":[],"units":"980 kits; 980 kits; 980 kits; 980 kits; 980 kits; 980 kits; 980 kits; 980 kits; 980 kits","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=99301","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7d3dacdde13a03b8","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=99301","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2779-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116I","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYKMBNDL116I    UDI-DI 10198459644764    Lots 26ABL226   26BBD710"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2780-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    DAVINCI PROSTATE PACK\t  \tDYNJ68477L  \tDYNJ68477M","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJ68477L    UDI-DI 10198459487866    Lots 25HMF458   25LME235  DYNJ68477M    UDI-DI 10198459678738    Lots 26CMK219   26EMG622"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2781-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    \t  UROLOGY ROBOTIC PROCEDURE PACK\t  \tDYNJ0945779U","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJ0945779U    UDI-DI 10195327632656    Lots 25IMC004   25JMD942   25JMJ441   25LMG068"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2782-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    NON MB DAVINCI LITHOTOMY SM PK\t  \tDYNJT6105","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJT6105    UDI-DI 10198459539381    Lots 25JBM474   25LBS203"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2783-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    PROSTATE ROBOTIC\t  \tDYNJ901822B","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJ901822B    UDI-DI 10195327319182    Lots 25KBA955   26CBL889"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2784-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    ROBOTIC\t  \tCDS980523M","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"CDS980523M    UDI-DI 10195327508913    Lots 25KBJ177   25LBO527   26ABT761"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2785-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    RR-DAVINCI PROSTATE ACCESSORY\t  \tDYNJ63392F","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJ63392F    UDI-DI 10198459315572    Lots 25GLA905   25HLA240   25HLA894   25JLA091   25KLA775   25LLA985   26ALA670"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2786-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    SM-LAPAROSCOPIC PROSTATE PAC\t  \tDYNJ61206J","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYNJ61206J    UDI-DI 10198459488597    Lots 25IMF461   25LMG907"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99301","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, MD. PA, and TX.","recall_number":"Z-2787-2026","product_description":"Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116G","product_quantity":"980 kits","reason_for_recall":"Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.","recall_initiation_date":"20260608","center_classification_date":"20260723","report_date":"20260729","code_info":"DYKMBNDL116G    UDI-DI 10198459156991    Lots 25GBG086   25JBF391   25KBA114   25KBN017   25LBQ601"}]}}