Due to a manufacturing issue, red particulates present in the expressed composite.
Ultradent Products
23 recalls • • Categories: Infusion Pumps, Other Medical Devices, Diagnostic Equipment, Other Foods, Surgical Instruments
Due to a manufacturing issue, red particulates present in the expressed composite.
Due to a manufacturing issue, red particulates present in the expressed composite.
🏥 Medical Devices Class I - Dangerous
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
🏥 Medical Devices Class I - Dangerous
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Dental varnish has the possibility of having an unpleasant and off flavor.
🏥 Medical Devices Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
🏥 Medical Devices Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
🏥 Medical Devices Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
🏥 Medical Devices Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
🏥 Medical Devices Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
🏥 Medical Devices Class I - Dangerous
There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
🏥 Medical Devices Class I - Dangerous
Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
🏥 Medical Devices Class I - Dangerous
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
🍎 Food Class I - Dangerous
Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.
🏥 Medical Devices Class I - Dangerous
Orthodontic brackets distributed was incorrectly labeled.
🏥 Medical Devices Class I - Dangerous
Incorrect packaging of regular set and fast set cartridges.
🏥 Medical Devices Class I - Dangerous
Incorrect packaging of regular set and fast set cartridges.
Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.
🍎 Food Class I - Dangerous
Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.