“Healthmark Mesh Tip Protectors: No FDA Clearance Recalled.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49745-healthmark-mesh-tip-protectors-no-fda-clearance-recalled. Based on FDA recall #Z-1943-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1943-2026%22&limit=1).
The FDA announced on March 12, 2026, that Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors CSW-03-2 Open-end and CSW-04-4.0 Closed-end styles because the products lack FDA clearance. The recall affects 4,291,797 units distributed nationwide.
The recalled devices do not have FDA clearance, according to the FDA.
Context
GovInfoNow's records show Healthmark Industries Co., Inc. has two other recalls on record since May 2, 2025. On July 29, 2026, the company recalled ProChek-II due to false test results from expired ingredients. On May 2, 2025, Healthmark issued a recall for Pre-filled Water Syringes linked to contamination risks. Other recent recalls of similar products include Medline Control Syringes and Manifold Kits (Feb. 25, 2026), Medline Angiography Kits (Feb. 25, 2026), and Covidien Mon-a-Therm Temperature Probe (April 23, 2026).
How to tell if you have this one
Check for model numbers CSW-03-2.0 or CSW-04-4.0 on the product. All lots are affected, so no specific batch numbers are listed.
Brand
Healthmark
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify if your protector is CSW-03-2.0 (open-end) or CSW-04-4.0 (closed-end).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1943-2026 (March 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1943-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.