Complete FDA and NHTSA recall records dated in January 2025.
These records include useful source details for the selected month.
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.
Lack of 510(k) clearance.
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…
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…
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.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Potential for signal drift in specific lots of BD PCR Cartridges.
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).
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 5820-107-430 but package contains a 5820-107-530 device or vice…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Potential for hole in package compromising sterility of the medical kit.
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice…
Lack of 510(k) clearance.
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…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Potential contamination with Listeria monocytogenes.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
