Heartware, Inc.: 72 FDA recall reports
Every medical device recall the FDA has published for Heartware, Inc.. The fault, and how the agency graded it.
72Reports
35Class I
63Ongoing
2023-12-13Most recent
35 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Z-0478-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
- Where it went
- Worldwide
- How much
- 7438 units
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Z-0482-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
- Where it went
- Worldwide
- How much
- 126 units
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Z-0481-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- Where it went
- Worldwide
- How much
- 126 units
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Z-0475-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
- Where it went
- Worldwide
- How much
- 45 units
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Z-0479-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
- Where it went
- Worldwide
- How much
- 10287 units
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Z-0483-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
- Where it went
- Worldwide
- How much
- 125
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Z-0476-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
- Where it went
- Worldwide
- How much
- 380 units
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Z-0477-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
- Where it went
- Worldwide
- How much
- 892 units
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Z-0480-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Product
- 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
- Where it went
- Worldwide
- How much
- 6 units
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech,
Z-1993-2023 · Class II · reported 2023-06-28 · Ongoing
- Why it was recalled
- Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
- Product
- HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
- Where it went
- Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
- How much
- 19 units
HeartWare Model 1100
Z-0742-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare Model 1100
- Where it went
- Worldwide distribution.
- How much
- 45 units
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Z-0747-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF 1104CA-CLIN
- Where it went
- Worldwide distribution.
- How much
- 6 units
HeartWare Model 1101
Z-0743-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare Model 1101
- Where it went
- Worldwide distribution.
- How much
- 82 units
HeartWare HVAD Pump Kit, REF 1103
Z-0745-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF 1103
- Where it went
- Worldwide distribution.
- How much
- 5704 units
HeartWare HVAD Pump Kit, REF 1104
Z-0746-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF 1104
- Where it went
- Worldwide distribution.
- How much
- 10320 units
HeartWare HVAD Pump Kit, REF MCS1705PU
Z-0750-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF MCS1705PU
- Where it went
- Worldwide distribution.
- How much
- 146 units
HeartWare Model 1102
Z-0744-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare Model 1102
- Where it went
- Worldwide distribution.
- How much
- 892 units
HeartWare HVAD Pump Kit, REF 1205
Z-0749-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF 1205
- Where it went
- Worldwide distribution.
- How much
- 126 units
HeartWare HVAD Pump Kit, REF 1104JP
Z-0748-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Product
- HeartWare HVAD Pump Kit, REF 1104JP
- Where it went
- Worldwide distribution.
- How much
- 73 units
Class I
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Z-1512-2022 · Class I · reported 2022-08-24 · Ongoing
- Why it was recalled
- Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
- Where it went
- Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.
- How much
- 19616 batteries
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Z-1103-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Where it went
- Finland and Turkey
- How much
- 667 units
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Z-1106-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Where it went
- Finland and Turkey
- How much
- N/A
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Z-1104-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- Where it went
- Finland and Turkey
- How much
- 510 units
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Z-1105-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- Where it went
- Finland and Turkey
- How much
- 59 units
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Gu
Z-1107-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)
- Where it went
- Finland and Turkey
- How much
- 645 units
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Z-1102-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Product
- HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- Where it went
- Finland and Turkey
- How much
- 236 units
HeartWare Ventricular Assist Device (HVAD) System
Z-0726-2022 · Class II · reported 2022-03-16 · Ongoing
- Why it was recalled
- Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
- Product
- HeartWare Ventricular Assist Device (HVAD) System
- Where it went
- Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
- How much
- 197,889 units
Medtronic HVAD Pump Implant Kits
Z-2478-2021 · Class II · reported 2021-09-22 · Ongoing
- Why it was recalled
- There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
- Product
- Medtronic HVAD Pump Implant Kits
- Where it went
- Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, Latvia, LEBANON, LITHUANIA, LUXEMBOURG, Macedonia, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, Poland, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM
- How much
- 11851 (potentially active, US); 1995 (active, US)
Class I
HeartWare HVAD Pump Implant Kit, REF 1125
Z-2190-2021 · Class I · reported 2021-08-18 · Ongoing
- Why it was recalled
- Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
- Product
- HeartWare HVAD Pump Implant Kit, REF 1125
- Where it went
- Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
- How much
- 4078 units
Class I
HeartWare HVAD Pump Implant Kit, REF 1153
Z-2191-2021 · Class I · reported 2021-08-18 · Ongoing
- Why it was recalled
- Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
- Product
- HeartWare HVAD Pump Implant Kit, REF 1153
- Where it went
- Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
- How much
- 163 units
Showing the 30 most recent of 72. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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