Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
22,462 detailed records are currently available in this category.
Attachments may not mate with the tooth as intended in the digital treatment design.
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…
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
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…
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…
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…
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…
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…
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…
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.
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…
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…
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.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
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…
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…
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…
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…
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…
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…
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…
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…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
