Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Vygon MFG, Inc., dba/ Churchill Medical Systems
Class I - Dangerous
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics
Class I - Dangerous
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Class I - Dangerous
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
Abbott Gmbh & Co. KG
Class I - Dangerous
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Class I - Dangerous
The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.