Like many first-time parents, Jon Borgese, a tech executive in Manhattan, had heard the buzz around the Baby Brezza formula maker, a countertop device that automatically dispenses warm bottles of formula at the touch of a button.
But after Mr. Borgese and his wife, Nicole, started giving the machine-mixed formula bottles last year to their 2-month-old daughter, Lily, she became fussy and began to look thin, he said. The couple rushed her to the pediatrician, who confirmed that Lily was losing weight and sent her for medical tests to determine the cause.
The problem was the Baby Brezza gadget, which had dispensed watery formula with insufficient nutrients for the baby, said Dr. Julie Capiola, Lily’s pediatrician. Mr. Borgese said he had since filed two class-action lawsuits against the machine’s maker, claiming the device was defective.
“You don’t want any baby or any parent to go through this,” he said, adding that Lily gained weight once the family stopped using the formula maker. “It was very, very upsetting.”
Mr. Borgese was one of many parents who have reported issues with the Baby Brezza formula machine, which was the top-selling baby feeding accessory in the United States over the last two years, according to the NPD Group, a market research company. On Amazon, Facebook, Better Business Bureau and parenting forums, people have posted more than 100 complaints saying the machines dispensed incorrect or inconsistent amounts of water or baby formula.
Separately, five pediatricians described to The New York Times how they had recently treated babies — whose parents had fed them Brezza-dispensed bottles — for failure to thrive, a condition caused by lack of nutrients. The doctors said the health risks could be even more severe because infants’ digestive systems aren’t developed enough to process formula that is too watery or too concentrated.
“It’s fine if it’s your coffee machine and you get more caffeine,” said Dr. Ari Brown, a pediatrician in Austin, Texas. But when it comes to infant formula, she has warned parents against using automated devices like the Baby Brezza, saying it “could potentially be harmful.”
David Contract, marketing team lead for the Betesh Group, a private company in Newark that makes the Baby Brezza devices, said the company had carefully calibrated the machines to work with more than 2,000 types of baby formulas and regularly tested the devices for precision. He said people must clean the machines frequently to prevent powder buildup, which could cause the systems to dispense watery formula — requirements he compared to installing infant car seats correctly.
“We are confident our machine works properly and accurately when it’s used right,” he said. He later added, “I do think there are people who don’t use it properly, who get a bad outcome, who get a watery bottle because they’re not cleaning, they’re not using the right settings.”
Mr. Contract said the Betesh Group believed that the lawsuits were an “attempt by a plaintiff’s lawyer to troll for additional plaintiffs by seeking media attention.” The Brezza machine had no other insurance claims or lawsuits against it, he said.
The problems that families said they have had with the Brezza machines illustrate the risks of adopting novel health-related devices before they are on the radar of federal regulators.
While the Food and Drug Administration regulates infant formula as a food and the Consumer Product Safety Commission oversees the safety of “durable” baby products like cribs, each agency initially said the other was responsible for vetting possible inaccuracies with automated baby formula-dispensing machines.
Last year, the Consumer Product Safety Commission received two reports from health care professionals about how babies who had been fed formula mixed by the Brezza devices had “lost significant weight” or “had to be evaluated after drinking the formula.” Last month, the commission clarified that it was responsible for overseeing the devices and urged consumers to report any problems to saferproducts.gov.
“Is anybody overseeing devices like this?” said Dr. Gayle S. Smith, a pediatrician in Richmond, Va., who said she had treated a Brezza-fed baby for failure to thrive. Or, she added, “is it babies who are supposed to fail to thrive in large enough numbers” before regulators intervene?
Mr. Contract said the machines were safe and met F.D.A. requirements for materials that come into contact with food.
Dr. Jacqueline Winkelmann, a pediatrician in Orange, Calif., said she had seen babies admitted to a hospital for weight loss because they were given bottles that had been mixed incorrectly by hand.
“I believe the Baby Brezza Formula Pro is a great way to ensure baby gets the right amount of nutrients in every bottle,” said Dr. Winkelmann, who consults for the Betesh Group.
The Betesh Group began selling automated formula-dispensing machines in 2013. The devices took off in 2018 when the company introduced a new model, the Baby Brezza Formula Pro Advanced. About half a million of the Brezza machines have been sold in the United States, the company said. Several similar machines are also available, with brand names like Baby EXO and Zomom.
To use the Brezza machine, people fill compartments for water and infant formula powder. They also set the machine to their desired number of ounces and specific type of formula. Mr. Contract said the devices can save parents several minutes per formula bottle, a welcome convenience in the middle of the night.
On BabyList, a popular site for expectant parents, more than 60,000 people — or about 6 percent of users — included the Brezza machines on their baby gift registries last year. Many parents swear by the devices.
“Instead of stumbling around in the middle of the night, you go into the kitchen, press a button on the machine, go get the baby and, by the time you get back to the kitchen, the warm bottle is ready,” said Linda Murray, senior vice president of consumer experience at BabyCenter, a pregnancy information site where parents have debated the pros and cons of the devices.
But Mr. Borgese and some other parents said that even when they carefully cleaned, set and filled the machines, the devices seemed erratic — sometimes producing opaque, milky-looking formula and other times dispensing watery-looking, translucent formula. In a federal class-action case he filed on Feb. 12, Mr. Borgese argued that the Betesh Group knew the devices did not mix the appropriate amount of formula and failed to warn parents and physicians.
Some parents who said the device was inconsistent ran their own experiments to test it.
“It was never giving you the right ratio,” said Paola Ortega, a brand strategist in Austin, who said the device dispensed too much formula powder and seemed to cause her son, Andrés, to vomit. She compared the machine-dispensed bottles with those she made by hand, she said, and found noticeable differences.
Another parent, Ortal Gefen in Orange, Conn., said she stopped using a Brezza machine to make bottles for her son, Henry, in 2017 after she discovered it “wasn’t consistent from one bottle to the next.”
She recently bought a newer model of the formula maker, which seemed more reliable. “When it works, it’s a lifesaver for parents,” Ms. Gefen said.
Some parents who contacted the Betesh Group said they were frustrated with its customer service. In complaints posted on the Baby Brezza Facebook page or filed with the Better Business Bureau, consumers said the company was slow to answer emails, blamed them for user error or told them that their one-year warranties were expired.
The Better Business Bureau has posted an F rating, a failing grade, for the Betesh Group, partly because of many complaints against the company and how long it took to respond.
Mr. Contract said the company had resolved most of the complaints submitted to the Better Business Bureau and believed that they were generally not “an accurate reflection of our customers’ satisfaction with our products.”
He added that the company’s customer service agents provide extensive troubleshooting, often helping people solve user errors like insufficient cleaning. As a precaution, he said, the machines are programmed to stop working and beep after every fourth bottle when they need to be cleaned.
The Betesh Group is developing a third-generation “smart” version of the device, which will be introduced this summer. Mr. Contract said it would include an app that enabled parents to direct the Brezza machine to prepare formula bottles from their smartphones.