Kala Red Light Face Mask Recalled by Health Canada in 2025

Health Canada has issued a Type II recall for the Kala Red Light Face Mask, a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co. Ltd. The recall, identified under reference number RA-77755, was initiated on June 2, 2025, and publicly updated on July 22, 2025. The recall concerns the product model KALA-01 with lot number 8191KY, and has been issued due to inadequate instructions in the user manual related to safe storage and handling.

What Products Are Being Recalled?

• Product Name: Kala Red Light Face Mask
• Model / Catalogue Number: KALA-01
• Lot / Serial Number: 8191KY
• Manufacturer: Shenzhen Kaiyan Medical Equipment Co. Ltd., Building #3 And Building #5, Shenzhen, Guangdong, China, 518103
• Category: Health Products – Medical Devices – Physical Medicine

Why Was This Recall Issued?

The recall was triggered by a performance issue identified with the device documentation. The user manual accompanying the Kala Red Light Face Mask does not provide sufficiently clear instructions to users regarding safe use and storage conditions. Specifically, the manual fails to adequately warn users against storing or operating the device in high-temperature environments. Additionally, the manual does not clearly caution users to protect the device from physical damage resulting from external impacts or falls from significant heights.

Health Canada has classified this as a Type II recall, which means that the use of, or exposure to, the recalled product may cause temporary adverse health consequences, or that the probability of serious adverse health consequences is remote. The inadequate labelling and instructions could lead users to inadvertently damage the device or use it in unsafe conditions, potentially compromising both the device performance and user safety.

Who Is Affected?

This recall affects members of the general public in Canada who have purchased or are currently using the Kala Red Light Face Mask (Model KALA-01, Lot 8191KY) manufactured by Shenzhen Kaiyan Medical Equipment Co. Ltd. Anyone who owns this specific model and lot number of the red light face mask device should take note of this recall and follow the recommended steps below.

What Should You Do?

• Check whether your Kala Red Light Face Mask matches the recalled model number KALA-01 and lot number 8191KY.
• Stop using the device in high-temperature environments immediately.
• Ensure the device is stored away from conditions that could cause physical damage, such as impacts or falls.
• Contact the manufacturer, Shenzhen Kaiyan Medical Equipment Co. Ltd., directly if you require additional information or clarification regarding the recall.
• Visit the official Health Canada recall page at the authority URL for the latest updates on this recall.

Official Statement

According to Health Canada, the issue relates to the clarity of the user manual accompanying the Kala Red Light Face Mask. The regulator states that users should not store or use the device in high temperatures, nor should they subject it to physical damage from external impact or a high fall. Health Canada is advising the general public to contact the manufacturer for additional information and to exercise caution when using this medical device until further guidance is issued. The recall was published by Health Canada and is categorized under health products as a medical device in the physical medicine segment.