FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Karl Storz Endoscopy
Class I - Dangerous
The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
DRG Instruments GmbH
Class I - Dangerous
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Bausch & Lomb Inc Irb
Class I - Dangerous
Possible dull knife edge
The seal integrity of the sterile bag containing the kits may be compromised.
Skull Anchor Bolts
Ad-Tech Medical Instrument
Class I - Dangerous
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Class I - Dangerous
The seal integrity of the sterile bag containing the kits may be compromised.
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Quantum Pump Console
Spectrum Medical
Class I - Dangerous
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Class I - Dangerous
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
EyeBOX Model OCL 02
OCULOGICA
Class I - Dangerous
A review of the user manual revealed that two precaution statements were missing.
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Roche Diagnostics Operations
Class I - Dangerous
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
Class I - Dangerous
code 7-102 Liquid Sensor Error