FDA DevicesClass II
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styl...
Published: May 6, 2026Recall ID: Z-1943-2026Category: devicesCountry: US
Reason for Recall / Hazard
Product does not have FDA clearance.
Product Description & Identification
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Affected Products
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Additional Source Details
| Field | Value |
|---|---|
| City | Fraser |
| State | MI |
| Event id | 98627 |
| Address 1 | 18600 Malyn Blvd |
| Code info | No UDI. All lots affected. |
| Postal code | 48026-3496 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 4,291,797 |
| Reason for recall | Product does not have FDA clearance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260312 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260424 |
Overview
- Recalling FirmHealthmark Industries Co., Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.