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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 4,291,797
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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