The Recall Desk
HighFDA (Devices)·Z-1943-2026·Announced 2026-05-06

Mesh Style Tip Protectors recalled lacking FDA clearance

Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device being distributed without required FDA clearance, which constitutes a risk-of-harm product. No reported injuries or illnesses are stated in the source, placing it at the high end of the scale per the rubric for medical devices lacking required authorization.

Plain-English summary

Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors in two styles: CSW-03-2.0 (open-end) and CSW-04-4.0 (closed-end). The product does not have FDA clearance.

All lots of the product have been affected and distributed nationwide in the United States. Consumers who have purchased this product should stop using it and consult with the manufacturer or the FDA for further guidance.

The recalled product

Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Manufacturer
Healthmark Industries Co., Inc.
Category
Medical Device — Surgical/Medical Instrument
Hazard
  • lack-of-fda-clearance
  • unapproved-medical-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • No UDI. All lots affected.

Distribution

Distributed nationwide across the United States.

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