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U.S. Department of Health and Human Services

Class 2 Device Recall Healthmark Mesh Style Tip Protectors

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 Class 2 Device Recall Healthmark Mesh Style Tip Protectorssee related information
Date Initiated by FirmMarch 12, 2026
Date PostedApril 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1943-2026
Recall Event ID 98627
Product Classification Endoscopic storage cover - Product Code OCU
ProductMesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Code Information No UDI. All lots affected.
FEI Number 1000160387
Recalling Firm/
Manufacturer		 Healthmark Industries Co., Inc.
18600 Malyn Blvd
Fraser MI 48026-3496
For Additional Information ContactMegan Ties
586-774-7600
Manufacturer Reason
for Recall		Product does not have FDA clearance.
FDA Determined
Cause 2		No Marketing Application
ActionFirm 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 in Commerce4,291,797
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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