19 hours ago
7
We were in the trenches. My seven-month-old baby had croup and his little body rattled through the night as he barked like a seal. Like many desperate parents wanting a solution, I drove to the nearest pharmacy.
In the third aisle, I thought I’d found the solution: a bulky, plastic humidifier called the Euky Bear.
An image of a blonde, sleeping baby graced the cardboard packaging, alongside the words “natural all-night relief from the symptoms of cold and flu”.
I never experienced that relief. Instead, it became a powerful case study that illustrated failures with the sales and oversight of medical devices – the very issues currently being exposed by this masthead’s Medical Malfunctions investigation.
The $58 device didn’t have an off button, and I worried it would overheat and start a fire once all the water had evaporated.
I was also left with a large, painful burn on my chest after my skin brushed the humidifier’s hot plastic while I was trying to turn it off one night. It took months to fade. I was one of the lucky ones.
Data scraped off the Therapeutic Goods Administration’s website as part of this masthead’s investigation into the toll of medical devices shows that Australians have lodged 55 adverse reports about the Euky Bear since 2021. At least two babies required skin grafts to treat third-degree burns after touching the device.
“Infant suffered a full thickness burn to two fingers requiring a skin graft,” one 2022 report from a consumer read.
In another incident, a parent reported that their Euky Bear had overheated and smoked out their baby’s bedroom with a “dangerous, plastic smell”. That baby was rushed to hospital after inhaling the smoke.
For years, the company received a steady stream of complaints about its device. Dozens of disgruntled customers took to the Euky Bear Facebook page to report their terrifying experiences.
One mother wrote that her vaporiser had started to smoke and almost caused a fire. Many raised concerns about the residue in the base of their vaporiser after use, and believed this was linked to the heating element disintegrating.
In September 2023, about 10 months after my dangerous encounter with the vaporiser, the company issued a partial recall of four batches of the Euky Bear. It said this was due to a “quality issue” that could lead to the heating element overheating.
My device was not among the four batches of the EBSV2013 model of the vaporiser that had been recalled.
I’m not someone who puts up with shoddy products, so I fired off an email to the manufacturer, Felton Grimwade & Bosisto’s Pty Ltd.
In the October 6, 2023 email, I asked for a refund and explained that the device had burnt me. If it had burnt me, what sort of damage might it inflict on a young child?
I also sounded the alarm about black sediment which accumulated at the bottom of the device after each use. “It is coming from the heating module which appears to be disintegrating,” I wrote.
The pharmacy where I purchased the device arranged for it to be sent to the manufacturer for safety testing.
A month later, the manufacturer emailed me to say that the device was “operating per normal”.
“We are confident that the vaporiser does not pose a risk, if used in accordance with the operating manual,” the customer services team wrote. They informed me that it would report my concerns to the Therapeutic Goods Administration.
I sent a quick response: “Thank you for running these tests on the machine. Unfortunately I will never feel safe using it again after my experience.”
The Euky Bear remained in my garage, gathering dust, and I didn’t think of it again until an image of the device flashed up on my colleague Liam Mannix’s computer screen at work earlier this year.
We were investigating medical devices, and our web scrapers were busily making sense of thousands of adverse event reports made to the TGA.
This device had caught Mannix’s attention because its manufacturers had issued the partial recall of a device model, only to issue a full recall of the same model 18 months later.
We wondered how often that happened and if the device manufacturer was trying to minimise the damage with a partial recall before the tide of adverse reports became too much to ignore.
Mannix’s sleuthing also alerted me that my Euky Bear, which had previously been declared safe by the manufacturers, had since been recalled. The company – despite having my email – never contacted me to tell me the device was now unsafe for sale.
The recall notice on the TGA website, published in May 2025, spoke to many of the concerns raised by customers. The device’s heating module could disintegrate, produce smoke, and the exposed element could cause severe burns. Consumers were told to stop using the device, cut its power cord and dispose of it.
While Euky Bear’s sponsor also cancelled its registration in March 2026, I was still able to purchase the device online almost two months later. On May 4, I bought another Euky Bear from Dick Smith, which was selling the device on behalf of a company called Cosmetics Squad.
While this second humidifier was a newer model not caught up in the recalls, it should have never been sold because it was no longer registered as a medical device.
It is a criminal offence to supply, sell or import unregistered medical devices in Australia. The offence carries financial penalties and even imprisonment.
I double-checked this interpretation with Dr Christopher Rudge, a health law expert from the University of Sydney, who was unequivocal.
“[I]t was unlawful to supply the unregistered device,” he said. “The newer model was never recalled, but the registration it depended on had been withdrawn.”
Rudge said that when the registration entry for the Euky Bear was cancelled, every online listing of the device also became an unlawful advertisement open to enforcement action by the TGA.
A spokeswoman for Felton Grimwade and Bosisto’s said the company had realised that a staged recall of its devices was not ideal.
“[W]e are sorry for the impact this has had on families,” she said.
She said the company had extended its recall to cover all batches of the EBSV2013 after further information came to light. She said the “quality issues” did not impact all devices in these batches.
“We are grateful for the trust Australian families place in us, and we are committed to continuing to earn it,” she said.
A TGA spokesman said the partial recall of the device was based on initial information available to the watchdog.
“The TGA received further safety and performance device incident reports concerning overheating elements, the device producing smoke or fumes and potential burns to consumers. A subsequent TGA investigation recommended that all batches be recalled,” he said.
The spokesman said therapeutic goods and devices must be registered to be lawfully supplied in Australia, unless they had an exemption, which Euky Bear did not.
“The TGA does not comment on individual matters beyond published compliance outcomes,” he said.
Cosmetics Squad emailed me last week, both as a customer and separately in response to my questions as a journalist, to say that the device’s registration was no longer valid.
“As a result, we’ll be issuing a refund for your order and will also send you a prepaid return label so you can return the item to us at no cost,” the customer support staff member wrote.
“We sincerely apologise for the inconvenience this has caused.”
Kogan, which owns Dick Smith, said it took prompt action – including removing listings and notifying customers – when potential issues and recalls were identified with its sellers’ products.
“We can confirm that the batch model of the product referenced was not subject to the recall. Regardless, this product has been removed from sale from our website,” a spokeswoman said. She made no comment about the product’s lack of registration.
Fortunately, our croup days are finally over and my scar has faded. I’ve received a refund for the recalled Euky Bear and should soon receive a refund for the unregistered one.
But it shouldn’t have taken 18 months and a trail of injured children for the manufacturer and Australia’s medical devices watchdog to take action.
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