The FDA Has Issued a Warning Letter to SNOO Manufacturers—What Families Need to Know

• The FDA has issued a warning letter to Happiest Baby, Inc., the makers of the popular SNOO Smart Sleeper Bassinet.
• The FDA says that the introduction of two new sleep sack sizes makes significant changes to how the product is used, and should have warranted a premarket submission to the FDA.
• In addition, there were quality control issues, such as stains and mold found on refurbished SNOOs.

Talk to some especially well-rested-looking new parents, and they’ll tell you their secret is the SNOO. The smart bassinet, created by The Happiest Baby on the Block founder Dr. Harvey Karp, automatically detects crying and responds with white noise and rocking with the goal of getting babies who wake up in the middle of the night back to sleep without parental intervention. In addition, there are sleep sacks that attach to the bassinet to keep babies on their backs in the hopes of cutting down on the risks of SIDS/SUID.

The Good Housekeeping Institute tests dozens of baby bassinets, and the SNOO always earns good marks from our at-home testers. “We could just put our babies down and they would fall asleep on their own within minutes,” one parent of twins told Good Housekeeping. “We never had to rock them to sleep and still don't to this day. It saved us so much time in the middle of the night, and I think really taught them how to fall asleep independently."

But the FDA has sent a warning letter to Happiest Baby, Inc., the makers of the SNOO, that might cause parents to hit the pause button on their SNOO purchases. Previously, the FDA gave the SNOO a De Novo approval, recognizing it as the first product of its kind that keeps babies sleeping on their backs. But now, the FDA is asking Happiest Baby to address how the company “significantly changed or modified the SNOO Smart Sleeper” since the designation.

The FDA says the kinds of sleep sacks that come with the SNOO have changed

According to the FDA, when the De Novo approval was granted, there were only three sizes of sleep sacks available: small (for babies who weigh 5 pounds to 12 pounds), medium (12 to 18 pounds), and large (18 to 25 pounds). Since then, Happiest Baby has added two sizes of sleep sacks: x-small (4 to 8 pounds) and XL (23 to 25 pounds), though Happiest Baby notes that customers who buy a new SNOO still only get the small, medium, and large sleep sacks (and purchasers of refurbished ones only get small and medium).

The introduction of the x-small size, the FDA notes, opens up the SNOO to parents of much smaller babies. “This change in the intended patient population leads to a significant change in the device’s existing risk profile because lower birthweight/preterm infants are at an increased risk of SIDS/SUID,” it writes. The FDA has asked to review additional data “to evaluate the impact of these changes.”

There’s an additional risk of caregivers using an x-small sleep sack on a baby who is too big for it. “The X-Small Sleep Sack could be too tight on the infant and compress vital organs, limit diaphragmatic movement, and result in respiratory compromise,” the FDA notes.

The opposite problem is true of the x-large sleep sack. “The increased length of the X-Large Sleep Sack introduces extra fabric, and the increased chest width creates additional space around the infant,” the FDA notes. “Together, these changes increase the risk that the X-Large Sleep Sack could ride up and cover the infant’s mouth or neck, which could result in respiratory compromise, suffocation, or death.”

What caregivers can do: Make sure the sleep sacks in use are only the small, medium, or large sizes that the FDA has already approved. “If you are using our small, medium, and large SNOO Sacks, you can continue to use them with confidence,” a representative for Happiest Baby, Inc. told Good Housekeeping in an email. “We are committed to addressing the FDA’s comments regarding the extra-small and extra-large SNOO Sacks.”

The FDA found issues surrounding the cleanliness of refurbished SNOOs

Since the SNOO is only used for such a short period, it makes sense that families would want to save some money by renting a bassinet or getting a refurbished one. But the FDA raised concerns about the quality control on the used items, which has led to some customer complaints.

“The complaints reported stains, soiling from bodily fluids, and overall unsanitary conditions of certain SNOO Smart Sleeper devices that were sent to customer,” the FDA wrote. “Your firm’s complaint investigation revealed that all four dirty SNOO Smart Sleeper devices originated from your refurbisher.” Mold was also found on some bassinets and mattress covers.

What caregivers can do: “About two years ago we terminated our relationship with one of our third-party refurbishing partners after discovering they were not fully following our strict cleaning protocols,” a rep from Happiest Baby, Inc. said. “We look forward to sharing with the Agency all our efforts to strengthen our processes and to satisfy their requirements for record keeping, reporting, and quality management.”

Still, it’s probably best to follow expert-recommended guidelines about secondhand baby gear and what is okay to thrift, reuse, or get refurbished—unfortunately, it’s recommended to get strollers, car seats, and bassinets or cribs new to ensure they conform to the most recent safety laws. And, for the gear that is old or secondhand, make sure to check the Consumer Product Safety Commission to see if there are any current recalls.