FDA recall, , Moderate risk
Healthmark Mesh Style Tip Protectors
Mesh Style Tip Protectors lack FDA clearance.
Summary by Recall Canary from the FDA notice
What happened
Healthmark Industries Co., Inc., of Fraser, Michigan, recalled Mesh Style Tip Protectors CSW-03-2.0 Open-end style and CSW-04-4.0 Closed-end style because the product does not have FDA clearance. The recall began March 12, 2026, and was added to the FDA's Enforcement Report on April 24, 2026. The product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
- Lot code
- No UDI. All lots affected.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Healthmark Industries Co., Inc.Fraser, Michigan
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98627
- Recall number
- Z-1943-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
All recalls from Healthmark Industries Co., Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
