Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
All Recalls
95,018 total recalls in our database
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Medline Industries
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Integra LifeSciences Corp. (NeuroSciences)
Potential packaging failures, which could lead to a breach in the sterile barrier.
foreign material (small hard plastic fragments)
Products contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40
Undeclared allergen - milk. Product contains butter; cream is listed as a sub-ingredient of the butter, but milk is not declared in the ingredients or a contains statement.
Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination.
Carrot Top Kitchens Lime Ginger Hummus; contains chickpeas, tahini, fresh ginger, lime juice & zest, salt; 8 oz.
Carrot Top Kitchens
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
Carrot Top Kitchens
Contains undeclared sesame
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Carrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
Carrot Top Kitchens
Contains undeclared sesame
Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination.
Foreign material. During production, the firm found pieces of blue plastic in a filter.