FDA recall Z-1943-2026
Healthmark Industries Co., Inc. · Class II · device
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Reason for recall
Product does not have FDA clearance.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-03-12
- Report date
- 2026-05-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Fraser, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2026