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December 2, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on November 29, 2024. To view listings for other dates, see CDRH New - News and Updates.

• Class I Recalls
  • Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle
  • Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm
  • Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
  • Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Administrative Detention and Banned Medical Devices