Z-1943-2026Class II

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Name: Z-1943-2026 Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Creator: Healthmark Industries Co., Inc.
Published: 2026-03-12
License: https://open.fda.gov/license/

Healthmark Industries Co., Inc. / initiated 2026-03-12 / Open, Classified

FDA source

Healthmark Industries Co., Inc. began a recall of Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style on 2026-03-12. FDA classified it as Class II and gives the reason as "Product does not have FDA clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1943-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-12
Posted: 2026-04-24
Recalling firm: Healthmark Industries Co., Inc.
Product: Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Product code: OCU Endoscopic Storage Cover
Reason for recall: Product does not have FDA clearance.
FDA root cause: No Marketing Application
Action: Firm began notifying customers on March 12, 2026 via email and phone call. The device has been discontinued. Customers were asked to discontinue the use of the Mesh Style Tip Protectors. Unused product may be returned for credit.
Quantity in commerce: 4,291,797
Distribution: US Nationwide distribution.
Product codes and lots: No UDI. All lots affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24

Product code OCU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)