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

• 8device recalls (since 1 Jan 2023)
• 1510(k) clearances (since 1 Jan 2023)
• 559side effect reports (reports received since 1 Jan 2023)

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

• 22Nov2025

  Material, Quality Control, Semen Analysis

  Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate d…

  Z-1262-2026
• 22Nov2025

  Sperm, Antigen, Antiserum, Control

  Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate d…

  Z-1263-2026
• 3Nov2025

  Anti-Müllerian Hormone Test System

  Reason: Distribution without premarket approval/clearance.

  Z-0737-2026
• 4Sep2024

  General Surgery Tray

  Reason: XXX

  Z-0166-2025
• 8Apr2024

  I.V. Start Kit

  Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pa…

  Z-3021-2024
• 22May2023

  Visual, Pregnancy Hcg, Prescription Use

  Reason: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" K…

  Z-0061-2024
• 22May2023

  Test, Luteinizing Hormone (Lh), Over The Counter

  Reason: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" K…

  Z-0062-2024
• 15May2023

  Orthopedic Tray

  Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

  Z-2338-2023

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

• 28Aug2026

  Vitrification Freeze Kit And Thawing Kit (cs-ivf-fk; Cs-ivf-tk)

  Company: CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.

  K254261

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

1. 1Abortion spontaneous65 reports
2. 2Maternal exposure during pregnancy36 reports
3. 3Ovarian hyperstimulation syndrome33 reports
4. 4Headache32 reports
5. 5Fatigue25 reports
6. 6Nausea25 reports
7. 7Abdominal distension24 reports
8. 8Dizziness22 reports
9. 9Injection site pain20 reports
10. 10Pregnancy17 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.

• Teenage births
• Children per woman

• Women's health
• Diagnostics and lab testing