Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style recall (Healthmark Industries Co., Inc.)
Medical deviceClass IIOngoing
Summary: Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style. Reason: Product does not have FDA clearance.
What is being recalled
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Why
Product does not have FDA clearance.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
No UDI. All lots affected.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1943-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 12, 2026 |
| Reported | May 6, 2026 |
| Company | Healthmark Industries Co., Inc. |
| Company location | Fraser, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,291,797 |
More recalls from Healthmark Industries Co., Inc. · all medical device recalls · recalls from March 2026