Recall of soother

Independent laboratory tests showed that traces of BPA were detectable in some production batches (Lots006 to 011). All other batches (Lots001 to 005) were not affected.
As a precautionary measure and in the interests of maximum product safety, we immediately stopped production and recalled all pacifiers – both in stores and online.

We immediately informed all points of sale and affected customers, set up an information website, and activated a hotline for questions and returns, which has since been closed. At the same time, comprehensive investigations were launched to clarify the exact cause of the contamination and to ensure that production could be resumed safely.

It is important to note that BPA is not and has never been a component of our pacifiers. The measured amount came from an undesirable external contamination in the production process, which we remedied as quickly as possible.

The investigations were carried out by accredited, independent testing laboratories in accordance with the applicable standards (EN 1400). The results were published on September4, 2025 (ZPStest 09/25, pp. 20–24).

In the saliva simulator, a BPA value of 19 μg/kg was measured for the Curaprox pacifier. The minor contamination affected only the plastic shield. The teat, made of medical-grade silicone, was completely BPA-free.

Different regulations set different limits for BPA:

• The EN 1400 standard: 0.01 mg/l in saliva simulant (equivalent to 10 μg/kg)
• Regulation (EU) 10/2011: 0.05 mg/kg (equivalent to 50 μg/kg)
• From July 20, 2026, an even lower limit value will apply (≤1 μg/kg, total content)
• The currently valid and binding EU Toy Safety Directive sets a limit value of 40 μg/l

Our measured value of 19 μg/kg was therefore in the very low range. According to current scientific knowledge, such traces are not considered acutely harmful to health and are classified as material or environmental contamination. Authorities such as the German Federal Institute for Risk Assessment (BfR) do not consider such small amounts to pose a health risk.
In general, toys contribute very little to overall BPA intake. Furthermore, under normal use, it is not expected that significant amounts will transfer from the plastic shield to the pacifier. The total daily intake from food and everyday objects is well below the levels at which health effects would be expected. Nevertheless, it makes sense to keep BPA exposure as low as possible – which is why we are taking consistent action.

No – according to the authorities, there is no acute health risk. The traces of BPA measured were very low. Nevertheless, as a precautionary measure, we decided to recall all affected pacifiers. The safety of children is always our top priority.
Our experts have determined the following:

• The measured amounts of BPA did not pose an acute risk to children.
• The possible long-term effects of BPA are still being researched – which is why authorities generally recommend avoiding unnecessary exposure.
• The additional risk posed by a pacifier is very low compared to overall everyday exposure (e.g., food or plastic containers).
• The tolerable daily intake is calculated for long-term exposure (70 years) and is designed to provide a safety margin.

BPA can occur in many sources in everyday life, e.g., in house dust or certain plastic objects. That is precisely why we are taking consistent action and removing every potential source – including our pacifiers affected by contamination.

Lot numbers 006, 007, 008, 009, 010 and 011. You can find the Lot number on the front right side of the soother.

We informed relevant authorities and this recall happened in close coordination with them.

We are strengthening our testing and quality assurance processes, improving internal workflows, and working with authorities, independent laboratories, and a scientific advisory board.