Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Summary
The FDA issued a Class II for Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styl by Healthmark Industries Co., Inc.. Reason: Product does not have FDA clearance..
Details
Source
Device Recall
External ID
Z-1943-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Lot/Code Info: No UDI. All lots affected.
Quantity Affected: 4,291,797
Reason for Recall
Product does not have FDA clearance.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-12
Company
Fraser, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Healthmark Industries Co., Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Healthmark Industries Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Healthmark Industries Co., Inc. have FDA actions?
Healthmark Industries Co., Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1943-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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