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Open, Classified

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

FDA Recall Z-1943-2026 · Posted 2026-04-24

Recalling FirmHealthmark Industries Co., Inc.
Recall StatusOpen, Classified
Product CodeOCU
Date Initiated2026-03-12
Product Quantity4,291,797

Reason for Recall

Product does not have FDA clearance.

Firm Action

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

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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