Parents who use SNOO products may want to check the size of their baby’s sleep sack.
Happiest Baby announced a voluntary recallThursday, Aug. 7, for its extra-small (XS) and extra-large (XL) SNOO Sacks after the company was informed by the U.S. Food and Drug Administration that those two sizes required FDA premarket authorization.
The company is asking customers to discontinue use and discard any XS or XL SNOO Sacks they have.
The recall does not include the SNOO Smart Sleeper or the small, medium and large SNOO Sacks, which received FDA De Novo authorization in 2023. It also does not affect Sleepea swaddle sacks, including the XS and XL sizes, because those products are designed for use outside of a SNOO.
Why Are the XS and XL SNOO Sacks Being Recalled?
According to Happiest Baby, the XS and XL SNOO Sacks were introduced after the company’s original FDA De Novo submission and therefore were not included in that review.
The sizes also differ from the FDA-authorized versions. The XS SNOO Sack is ¾ inch narrower and 2 inches shorter than the authorized small size, while the XL SNOO Sack is ½ inch wider and 3 inches longer than the authorized large size.
The FDA told Happiest Baby that those differences could result in a fit that is either too loose or too tight.
Happiest Baby said it has not received any reports of injuries related to the use of the XS or XL SNOO Sacks.
What Should Customers Do?
Anyone who purchased an XS or XL SNOO Sack in the U.S. through Happiest Baby’s website can apply for a refund or exchange for a small, medium or large SNOO Sack through the company’s support page.
Customers who purchased an XL SNOO Sack through Amazon should contact Amazon directly at 888-280-4331, according to the recall announcement.
Parents with questions can also contact Happiest Baby’s Customer Care team through the company’s help center.
The U.S. Consumer Product Safety Commission recommends that parents regularly check for recalls involving infant products and follow safe-sleep guidance. The agency advises placing babies on their backs and keeping cribs, bassinets and other approved sleep spaces free of loose blankets, pillows and other soft objects.
For families using a SNOO, the important takeaway is that this recall is limited to the XS and XL SNOO Sacks. The SNOO Smart Sleeper and small, medium and large SNOO Sacks are not part of this recall.
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