On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W…
Class IIFDA: OngoingBecton, Dickinson and Company, BD Bio Sciences
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W…
Class IIFDA: OngoingBecton, Dickinson and Company, BD Bio Sciences
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the…
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W…
Class IIFDA: OngoingBecton, Dickinson and Company, BD Bio Sciences
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and…
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service…
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall…
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the…
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window…
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non…
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
About the 2025 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.