Otteroo Confirms That Their LUMI and MINI Neck Floats Are Safe for Use
SAN FRANCISCO, November 22, 2022 – Otteroo Corp., a San Francisco-based small business that popularized inflatable baby neck floats in the US market, is deeply saddened by the loss of a baby’s life, mentioned in the U.S. Consumer Product Safety Commission’s (CPSC) statement regarding Otteroo infant flotation rings.
Otteroo maintains that LUMI and MINI floats, when used with proper attention and care, are completely safe and strongly disagrees with the unjustified and alarmist claims made by the CPSC to stop using Otteroo products due to the risk of deflation (an inherent risk to all inflatables) leading to drowning.
CPSC’s statement is misleading because mere deflation of the Otteroo is not the hazard CPSC claims. Rather, a hazard may arise only if an adult is not closely supervising the infant while they are in Otteroo in the water.
Additionally, CPSC ignores the millions of safe Otteroo uses as well as the insufficient (police) evidence in the two cases they rest their stance on, CPSC warns against all use of the Otteroo and bases its warning on an impossible standard – that our inflatables must never deflate.
ALL inflatables – tires, soccer balls, inner tubes, swimming-pool toys – can deflate during use, through punctures or wear & tear, or storage. “This position of the CPSC would mean that no inflatables should be used in water with children. Their assertion that only our floats, which are designed with the highest quality materials and safety standards, should not be used because of the risk of deflation is irrational and unfair,” said Chiu.
To date, with the exception of the 2 cases mentioned by the CPSC, over 400,000 Otteroos on the market have been safely used millions of times by caregivers who understand the importance of closely watching infants while in the water – Otteroo or not.
Otteroo does many things to ensure that each Otteroo session is a safe and positive experience.
Otteroo asks parents to acknowledge, during the purchasing process, that they must always be right next to their infants when using Otteroo, and to check for leaks and fit prior to each use. This message is repeated several times in purchase and shipping confirmation emails, as well as on the instructional pamphlet and float itself.
As demonstrated in the 68 deflation cases (over 8 years) that CPSC misleadingly framed as “rescues,” parents have proven that they do understand the importance of close supervision when using the Otteroo and that they should not leave an infant in water alone. In every one of these cases, the infant was completely unharmed.
Without LUMI and MINI neck floats on the market, Otteroo strongly believes there will be a heightened risk to babies by the use of inferior, unsafe alternatives that are cheaply made and lack proper warnings and instructions coming from unregulated, overseas sellers. “Without Otteroo, parents, especially those who use it for aquatic therapy and have come to depend on it, will only be left with unsafe options,” said Chiu.
Rather than trying to force parents to stop using a safe and well-loved brand, Otteroo urges CPSC to recognize the benefits of Otteroo neck floats and work to establish safety standards for the product category, which will ensure that only high-quality versions with appropriate instructions and warnings – like Otteroo – are available.
“Years ago, the CPSC tried to get baby-sling manufacturers to recall their products. But after realizing that it was a product parents were not going to give up, the CPSC changed its mind and instead helped the industry strengthen its safety messaging,” said Chiu. However, several US companies went out of business in the interim.
Otteroo wants to convince the CPSC to do the same for the baby neck float category. “We believe that instead of shutting down responsible US-based companies and allowing unregulated, overseas products to flourish, we should be educating parents on bath and water safety and setting new standards for the product category,” said Chiu.
About Otteroo
Otteroo Corporation is a San Francisco-based, woman-owned small business that has been popularizing inflatable baby neck floats in the US market since 2014. Trusted and loved by parents, developmental experts and therapists, its patented transparent floatation device supports the baby’s head while leaving their arms and legs free to move without restriction in a gravity-reduced environment starting at 6 pounds. Since the company started in 2012, Otteroo has sold over 400,000 baby neck floats and has been invited to be a part of the University of California at San Francisco's incubator program for medical startups, to support therapists and their patients during water therapy interventions. For more information, visit otteroo.com.
Media Contact: Emi Kamiya, emi@otteroo.com
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The Short Version:
- Baby neck floats remain legal in the United States.
- The U.S. Consumer Product Safety Commission (CPSC) established a mandatory federal safety standard for neck floats that took effect in 2026.
- The 2022 U.S. Food and Drug Administration (FDA) safety communication is no longer publicly accessible on the FDA’s website.
- Active adult supervision remains essential whenever a baby is in or near water.
A Lot Has Changed Since 2022
In 2022, the FDA issued a safety communication regarding baby neck floats, particularly discussing concerns related to therapeutic use in infants with developmental conditions. The communication received significant media attention and sparked important conversations. Regulators, manufacturers, healthcare professionals, physical therapists, and families have to this day continued discussing how products in this category should be evaluated and regulated, and more broadly, infant water safety.
That communication is no longer publicly accessible on the FDA's website. While we cannot speak to the FDA's internal decision-making, parents researching neck floats today may notice that many articles still reference the communication, despite it no longer being accessible.
The CPSC Established a Federal Safety Standard
In 2025, the CPSC finalized a mandatory federal safety standard for neck floats. The rule includes requirements related to product performance and warning labels, and took effect in 2026.
For families and manufacturers alike, this represents an important milestone. Rather than leaving the category unregulated, or banning it outright, the CPSC established a framework intended to improve consistency and safety across products sold in the United States.
As a company, we support efforts to create clear safety expectations and standards for products used by infants and young children.
For families, the most important takeaway is that neck floats are no longer simply a subject of debate. They are now part of a federally regulated product category with defined safety requirements. While opinions may still differ about the category itself, manufacturers now have a clearer framework for designing, testing, and labeling these products.
Our Relationship With Regulators
Over the years, we have had extensive conversations with both the FDA and the CPSC. While there have been areas where our perspectives differed, we have always shared the same ultimate objective: infant safety.
We appreciate the difficult responsibility regulators carry when evaluating products intended for young children. We also believe that scientific inquiry, product innovation, and open dialogue play an important role in advancing safety. Our commitment has always been to participate in those discussions constructively and transparently.
Continuing Research and Development
Since our inception in 2014, there has been growing interest from clinicians, therapists, and researchers in understanding how aquatic environments may support infant movement and development.
Many families — including families of children with special needs — have shared their personal Otteroo experiences with us, the FDA, and the CPSC. These stories suggest that water, combined with Otteroo’s support, can create unique (and sometimes life-changing) opportunities for exploration and movement.
This potential deserves further study, and to that end, we continue to pursue research and regulatory pathways to help answer important questions with rigorous data, including our ongoing efforts to generate the evidence needed to support an FDA De Novo classification for a version of Otteroo intended for supervised therapeutic use.
What Hasn't Changed
While regulations evolve and standards improve, one thing has remained constant: any time a baby is in or near water, active adult supervision is essential.
No float, bath seat, inflatable, or water product can replace an attentive caregiver.
Stay within arm's reach. Keep your eyes on your baby. The whole time.
Looking Ahead
We are optimistic about the future of baby neck floats. The establishment of federal standards creates a clearer path forward for manufacturers, regulators, researchers, and families.
We hope to continue contributing to that future through product improvements, safety education, clinical research, and ongoing collaboration with clinicians, researchers, regulators, and families.
Most of all, we hope more families can safely experience the joy that comes when a baby discovers movement, curiosity, and confidence in the water. That simple moment — watching a baby explore, kick, splash, and smile — is what inspired Otteroo from the beginning, and it continues to inspire us today.
Important Safety Information
Otteroo LUMI is intended for supervised water play only. It is not a life-saving device and does not prevent drowning. Always follow all product instructions. Consult your pediatrician before beginning water activities if your baby has developmental concerns or special medical needs.