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The liquid tissue adhesive was marketed without FDA pre-market clearance.
Sterility of the device may be compromised due to a lack of package integrity
Patient files become mixed up due to a software defect.
Post operative complaints of cloudiness in the intraocular lenses.
Bottle contains less product than is declared on the label.
Vial contains less product than is declared on the label.
Some of the product pouches have holes in the seals.
latching mechanism failure
The device was produced without the required distal locking hole
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
FDA's analysis revealed defects (holes) in the latex gloves.
If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.