{"recall":{"id":"fda-device-99708","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Heraeus Medical GmbH (Dental Division) recalls 4 products","firm":"Heraeus Medical GmbH (Dental Division)","date":"2026-08-20","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).","code":"UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.","quantity":"33,727 units","number":"Z-3301-2026","classification":"Class II"},{"name":"PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).","code":"Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.","quantity":"59,660 units","number":"Z-3302-2026","classification":"Class II"},{"name":"PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A","code":"Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.","quantity":"20,523 units","number":"Z-3303-2026","classification":"Class II"},{"name":"PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A","code":"Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.","quantity":"","number":"Z-3304-2026","classification":"Class II"}],"reason":"Potential for monomer liquid leakage.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.","nationwide":true,"states":[],"units":"33,727 units; 59,660 units; 20,523 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=99708","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"cff546f8d2677d96","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=99708","record":[{"status":"Ongoing","city":"Wehrheim","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99708","recalling_firm":"Heraeus Medical GmbH (Dental Division)","address_1":"Philipp-Reis-Str. 8","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.","recall_number":"Z-3301-2026","product_description":"PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.    Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).","product_quantity":"33,727 units","reason_for_recall":"Potential for monomer liquid leakage.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.","more_code_info":""},{"status":"Ongoing","city":"Wehrheim","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99708","recalling_firm":"Heraeus Medical GmbH (Dental Division)","address_1":"Philipp-Reis-Str. 8","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.","recall_number":"Z-3302-2026","product_description":"PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.     Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).","product_quantity":"59,660 units","reason_for_recall":"Potential for monomer liquid leakage.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.","more_code_info":""},{"status":"Ongoing","city":"Wehrheim","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99708","recalling_firm":"Heraeus Medical GmbH (Dental Division)","address_1":"Philipp-Reis-Str. 8","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.","recall_number":"Z-3303-2026","product_description":"PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.    Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).  Component: N/A","product_quantity":"20,523 units","reason_for_recall":"Potential for monomer liquid leakage.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.","more_code_info":""},{"status":"Ongoing","city":"Wehrheim","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99708","recalling_firm":"Heraeus Medical GmbH (Dental Division)","address_1":"Philipp-Reis-Str. 8","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.","recall_number":"Z-3304-2026","product_description":"PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.     Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).  Component: N/A","product_quantity":"","reason_for_recall":"Potential for monomer liquid leakage.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.","more_code_info":""}]}}