Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Starcam/Camstar GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don’t use in neonates/infants, with target tidal volumes less-than50mL… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Zenith Alpha 2 Thoracic Endovascular Graft Affected devices may contain PTFE coating scrapings. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement Report31 statesnamed in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall ACCOLADE SR SL (Model L300) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACCOLADE DR SL (Model L301) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACCOLADE SR SL MRI (Model L310) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACCOLADE DR SL MRI (Model L311) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACCOLADE DR EL (Model L321) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACCOLADE DR EL MRI (Model L331) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall PROPONENT SR SL (Model L200) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall PROPONENT DR SL (Model L201) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L209 PROPONENT DR (VDD) SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L210 PROPONENT SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L211 PROPONENT DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L221 PROPONENT DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L231, PROPONENT DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L100, ESSENTIO SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L101, ESSENTIO DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L110, ESSENTIO SR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L111, ESSENTIO DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L121 ESSENTIO DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number L131, ESSENTIO DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number S701 ALTRUA 2 SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number S702, ALTRUA 2 DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number S722, ALTRUA 2 DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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