KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Cervical Extension Machine for Physical Therapy
MedX Holdings
Class I - Dangerous
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Baxter Healthcare
Class I - Dangerous
System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Horiba Instruments, Inc
Class I - Dangerous
HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes
Nerve Block Tray (Nerve Block convenience kit)
Centurion Medical Products
Class I - Dangerous
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Lumbar Extension Machine for Physical Therapy
MedX Holdings
Class I - Dangerous
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Class I - Dangerous
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Class I - Dangerous
The cuff inflation line may detach from the endotracheal tube during use.
Class I - Dangerous
Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Natus Medical Incorporated
Class I - Dangerous
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.