FDA Medical devices recall ·
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end… recall
- Recall number
- Z-1943-2026
- Date
- (initiated March 12, 2026)
- Company / brand
- Healthmark Industries Co., Inc.
18600 Malyn Blvd, Fraser, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,291,797
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Why was it recalled?
Product does not have FDA clearance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
No UDI. All lots affected.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1943-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.