Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA device recall Z-1943-2026 · posted 2026-04-24 · Open, Classified
Recall details
- Recalling firm
- Healthmark Industries Co., Inc.
- Reason for recall
- Product does not have FDA clearance.
- Action taken
- Firm began notifying customers on March 12, 2026 via email and phone call. The device has been discontinued. Customers were asked to discontinue the use of the Mesh Style Tip Protectors. Unused product may be returned for credit.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- OCU
- Quantity affected
- 4,291,797
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-03-12
- Date posted
- 2026-04-24
- Location
- Fraser, MI
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