United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye...
Lack of Assurance of Sterility
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl ...
Non-Sterility: Due to presence of Aspergillus penicillioides.
El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated pa...
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Potential presence of Salmonella.
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybe...
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz....
potential salmonella contamination
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide ...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panque...
Undeclared allergens: Milk and Soy
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM S...
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
6/11oz Sunflower Seeds Salted
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Product not adequately pasteurized
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Spring & Mulberry Sea Salt Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), indi...
Potential Salmonella contamination
Spring & Mulberry Mint Leaf Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ind...
Potential Salmonella contamination
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66...
Undeclared allergen, sesame.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.