Recall Z-1943-2026 ยท OCU Endoscopic Storage Cover
Healthmark Industries Co., Inc.
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
| Date | Apr 24, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| Reason | Product does not have FDA clearance. |
| Root cause | No Marketing Application |
| 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. |
| Quantity | 4,291,797 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.