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.
21,924 detailed records are currently available in this category.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
Potential for signal drift in specific lots of BD PCR Cartridges.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result…
Lack of 510(k) clearance.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
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.
