United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App...
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Med...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIO...
Incomplete seals on sterile product
Blue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. A...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT,...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-...
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients:...
Products contain undeclared soy, specifically soy lecithin.
Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produc...
Foreign object (stainless steel dust/flakes or shreds of plastic)
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized b...
Undeclared allergens (wheat and soy).
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ...
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Numbe...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, S...
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. ...
Foreign object (stainless steel dust/flakes or shreds of plastic)
Kroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353...
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella.
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product