FDA approvals and recalls

Gut health: 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.

Drug recalls

16 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

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

At the source

  • Endoscopic Injection Needle, Gastroenterology-Urology

    Reason: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur…

    Z-0163-2027

  • Endoscopic Ultrasound System, Gastroenterology-Urology

    Reason: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    Z-0306-2027

  • Endoscopic Ultrasound System, Gastroenterology-Urology

    Reason: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    Z-0307-2027

  • Endoscopic Ultrasound System, Gastroenterology-Urology

    Reason: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    Z-0308-2027

  • Endoscopic Ultrasound System, Gastroenterology-Urology

    Reason: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    Z-0309-2027

  • Hemostatic Device For Endoscopic Gastrointestinal Use

    Reason: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

    Z-3177-2026

  • System, Gastrointestinal Motility (Electrical)

    Reason: Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter a…

    Z-2669-2026

  • System, Gastrointestinal Motility (Electrical)

    Reason: The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

    Z-2950-2026

  • Endoscope Channel Accessory

    Reason: Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

    Z-2413-2026

  • Evacuator, Gastro-Urology

    Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

    Z-2718-2026

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

41,059 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. 1Diarrhoea3,081 reports
  2. 2Nausea2,941 reports
  3. 3Fatigue2,271 reports
  4. 4Vomiting2,019 reports
  5. 5Constipation1,452 reports
  6. 6Headache1,393 reports
  7. 7Asthenia1,342 reports
  8. 8Abdominal pain1,336 reports
  9. 9Abdominal pain upper1,308 reports
  10. 10Pain1,282 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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