Pet food and pet product recalls

The seam on the activity toy's house can open, allowing a young child access to the toy's filling, posing choking and ingestion hazards if placed in the mouth.

The recalled mugs can crack or break when filled with hot liquid, posing burn and laceration hazards.

Small metal wire pieces can be found in the pajamas, posing puncture and laceration hazards to young children.

Sterile extension sets were distributed without an expiration date

Potential contamination with foreign material (metal).

The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

Undeclared tree nut: Coconut

Product contains undeclared sugar. Full sugar root beer was packaged in bottles labeled "sugar free"

There are 7 reported software anomalies that may affect use of the device.

The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

The ride-on toy can tip forward when a young child is riding it, posing fall and injury hazards to children.

Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.

A fuse in the ATV's electrical system can fail during operation, which can result in sudden loss of engine power and headlights, posing a crash hazard.

Undeclared Wheat

A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained

The product is not able to provide irrigation.

The product is not able to provide irrigation.

The children's pajama sets fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

Screws can become loose and/or detach from the xylophone component of the activity tables, posing a choking hazard to young children.

Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

The product incorrectly contains sugar, which is not declared on the label.

The rattle's legs can break off, posing a choking hazard to young children.

Potential to contain undeclared peanuts

Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Product labeled to be Diet and Zero Sugar in the ingredient statement may contain sugar due to an production error.

Lack of Assurance of Sterility