{"recall":{"id":"fda-device-99807","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls 2 products","firm":"Medline Industries, LP","date":"2026-08-14","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS","code":"Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001","quantity":"1824 units","number":"Z-0086-2027","classification":"Class II"},{"name":"Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS","code":"Lot Numbers: 05425080001 05426040001","quantity":"835 units","number":"Z-0087-2027","classification":"Class II"}],"reason":"The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"1824 units; 835 units","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=99807","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d7c0923075479300","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=99807","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99807","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":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-0086-2027","product_description":"Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS","product_quantity":"1824 units","reason_for_recall":"The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame  tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.","recall_initiation_date":"20260814","center_classification_date":"20261005","report_date":"20261014","code_info":"Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001"},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99807","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":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-0087-2027","product_description":"Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS","product_quantity":"835 units","reason_for_recall":"The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame  tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.","recall_initiation_date":"20260814","center_classification_date":"20261005","report_date":"20261014","code_info":"Lot Numbers: 05425080001 05426040001"}]}}