Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
All Recalls
95,025 total recalls in our database
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Medtronic MiniMed
🏥 Medical Devices Class I - Dangerous
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Medline Industries
🏥 Medical Devices Class I - Dangerous
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Elekta Impac Software
🏥 Medical Devices Class I - Dangerous
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
Medtronic MiniMed
🏥 Medical Devices Class I - Dangerous
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Carroll-Baccari
🏥 Medical Devices Class I - Dangerous
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.
🏥 Medical Devices Class I - Dangerous
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Abbott Diabetes Care
🏥 Medical Devices Class I - Dangerous
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
🏥 Medical Devices Class I - Dangerous
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
🏥 Medical Devices Class I - Dangerous
The printed expiration dates are incorrect.
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Medline Industries
🏥 Medical Devices Class I - Dangerous
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
🏥 Medical Devices Class I - Dangerous
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
🏥 Medical Devices Class I - Dangerous
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
🏥 Medical Devices Class I - Dangerous
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Karl Storz, Model # 11161C2, Flexible Neuroscope
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.