United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
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.
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Spring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), in...
Potential Salmonella contamination.
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OP...
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.
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
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.
25# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz....
potential salmonella contamination
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 Rose Lassi 16 oz.
Product not adequately pasteurized
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...
Potential for thrombus formation during prolonged use of the introducer.
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.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...
Potential for thrombus formation during prolonged use of the introducer.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Nu...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Spring & Mulberry Blood Orange Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ...
Potential Salmonella contamination
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL He...
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, ...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Spring & Mulberry Mango Chili Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), i...
Potential Salmonella contamination