FDA Issues Two Medical Device Public Health Warnings

FDA publishes public health warnings

The Food and Drug Administration published public health warnings concerning TOPCARE ELASTIC BANDAGE and HUAKUN BV FILTER. Both advisories direct healthcare professionals and the general public not to purchase or use the named medical device products.

FDA Advisory No. 2026-1508 concerns TOPCARE ELASTIC BANDAGE. The FDA identified TOPCARE ELASTIC BANDAGE as an unnotified medical device product and issued a public health warning against its purchase and use.

FDA Advisory No. 2026-1506 concerns HUAKUN BV FILTER. The FDA identified HUAKUN BV FILTER as an unregistered medical device product and issued a public health warning against its purchase and use.

Products identified in the FDA advisories

• TOPCARE ELASTIC BANDAGE — identified by the FDA as an unnotified medical device product in Advisory No. 2026-1508.
• HUAKUN BV FILTER — identified by the FDA as an unregistered medical device product in Advisory No. 2026-1506.

According to the FDA, the warnings apply to healthcare professionals and the general public. The agency’s notices state that the two named products should not be purchased or used.

What the notices state

The FDA presented the notices as public health warnings. The TOPCARE ELASTIC BANDAGE advisory describes the product as unnotified, while the HUAKUN BV FILTER advisory describes the product as unregistered.

For medical device sales professionals, the notices identify specific product names and the FDA’s stated status for each product. The advisories also make clear that the agency’s warning is directed beyond healthcare settings to the general public.

The FDA published both advisories on the same date. Each notice focuses on a named medical device product and contains the agency’s instruction not to purchase or use it.

Key advisory distinction

TOPCARE ELASTIC BANDAGE is described in the FDA notice as unnotified. HUAKUN BV FILTER is described in the separate FDA notice as unregistered. In both cases, the FDA warns against purchase and use.