Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
All Recalls
95,038 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
🏥 Medical Devices 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.
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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
🏥 Medical Devices 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.
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Comprehensive RS Cleat CAP, Item No. 110300
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Wright Medical Technology
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
🏥 Medical Devices Class I - Dangerous
The incorrect outer carton box was used for the product.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.