Healthmark recalls mesh tip protectors CSW-03-2.0 and CSW-04-4.0 due to lack of FDA clearance. All units are affected.
Product does not have FDA clearance.
Healthmark is recalling two types of mesh tip protectors because they do not have FDA clearance. This means they may not be safe for medical use.
The product lacks FDA clearance, meaning it has not been approved for medical use. This could lead to unsafe medical procedures if used without proper regulatory oversight.
Healthmark mesh tip protectors CSW-03-2.0 (open-end) and CSW-04-4.0 (closed-end) are affected. Medical users are most at risk.
Check for model numbers CSW-03-2.0 or CSW-04-4.0 on the product. All lots are affected, so no specific batch numbers are listed.
Identify if your protector is CSW-03-2.0 (open-end) or CSW-04-4.0 (closed-end).
The product does not have FDA clearance, meaning it has not been approved for medical use.
All lots are affected; no specific batch numbers are listed.
The recall record does not specify a remedy, so no action is required beyond checking if the product is affected.
We’ve drafted a message you can send Healthmark to request your refund or repair — edit it as you like.
Subject: Recall Z-1943-2026 — Healthmark Healthmark Hello, I own a Healthmark that is covered by recall Z-1943-2026 from Healthmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
