Class I - Dangerous
Lack of 510(k) clearance.
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Other Medical Devices
🏥 Medical Devices • 15,809 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
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
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.
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
Lack of 510(k) clearance.
BD Pyxis MedStation 4000 Main, REF 303
CareFusion 303
Class I - Dangerous
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 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Class I - Dangerous
Lack of 510(k) clearance.
Bodor P and C series laser cutting machines
Jinan Bodor Cnc Machine Co
Class I - Dangerous
Non-compliant laser products
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
CareFusion 303
Class I - Dangerous
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 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
BD Pyxis MedStation ES (Med ES Main), REF 323
CareFusion 303
Class I - Dangerous
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 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
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.
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
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
Lack of 510(k) clearance.