FDA approvals and recalls

Biologics and biosimilars: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Device recalls

76 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0070-2027

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0071-2027

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0072-2027

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0073-2027

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0074-2027

  • Indicator, Biological Sterilization Process

    Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

    Z-0075-2027

  • Instrument, Biopsy

    Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

    Z-2707-2026

  • Instrument, Biopsy

    Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

    Z-2709-2026

  • Thoracentesis Tray

    Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

    Z-2657-2026

  • Catheter, Hemodialysis, Triple Lumen, Non-Implanted

    Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

    Z-2660-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

28 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

7,301 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Mucosal inflammation525 reports
  2. 2Cytomegalovirus infection reactivation378 reports
  3. 3Febrile neutropenia342 reports
  4. 4Acute kidney injury297 reports
  5. 5Diarrhoea282 reports
  6. 6Pyrexia265 reports
  7. 7Thrombotic microangiopathy261 reports
  8. 8Venoocclusive liver disease260 reports
  9. 9Thrombocytopenia241 reports
  10. 10Acute graft versus host disease226 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

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