Class IIOngoingZ-0033-2026
Medtronic MiniMed, Inc. recalls Medtronic
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Medtronic MiniMed, Inc…CAOct 8, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 961–972 of 2,908 recalls
Class IIOngoingZ-0032-2026
Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress wi…
Beckman Coulter Inc.CAOct 8, 2025
Class IIOngoingZ-0030-2026
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions software version 14.2.2
Due to software issue, radiology reports may not be fully displayed when viewing.
CHANGE HEALTHCARE CANA…Oct 8, 2025
Class IIOngoingZ-0027-2026
Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Aesculap AGOct 8, 2025
Class IIOngoingZ-0026-2026
Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Aesculap AGOct 8, 2025
Class IIOngoingZ-0025-2026
Northeast Scientific Inc. recalls NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0024-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0023-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0022-2026
Northeast Scientific Inc. recalls NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number:…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0021-2026
Northeast Scientific Inc. recalls NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-0…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0020-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-1…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0019-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-1…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025