Class I - Dangerous
Lack of 510(k) clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
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 versa).
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class I - Dangerous
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 versa).
Class I - Dangerous
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class I - Dangerous
Lack of 510(k) clearance.
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Baxter Healthcare
Class I - Dangerous
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Class I - Dangerous
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).
Class I - Dangerous
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
BD PCR Cartridges used with MAX System. Model Number: 437519
Becton Dickinson &
Class I - Dangerous
Potential for signal drift in specific lots of BD PCR Cartridges.
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic Perfusion Systems
Class I - Dangerous
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class I - Dangerous
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
Class I - Dangerous
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 result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Class I - Dangerous
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 in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Class I - Dangerous
Lack of 510(k) clearance.