CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Mesh Style Tip Protectors Csw-03-2.0 Open-end style recalled
Healthmark Industries is recalling Mesh Style Tip Protectors Csw-03-2.0 Open-end style Csw-04-4.0 Closed-end style, distributed nationwide in the US. The recall was initiated on 12 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1943-2026
- FDA event ID
- 98627
- Recalling firm
- Healthmark Industries, Fraser, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Mar 2026
- FDA classified
- 24 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Mar 2026 | Recall initiated by company | |
| 24 Apr 2026 | Classified by FDA | +43 days |
| 6 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product does not have FDA clearance.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Product does not have FDA clearance.
Which lots are affected?
No UDI. All lots affected.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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