Exact FDA event identifier

Event 98627

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 12, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Healthmark Industries Co., Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1943-2026

Recall number: Z-1943-2026
Initiated: March 12, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Healthmark Industries Co., Inc.
Quantity: 4,291,797

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product does not have FDA clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not have FDA clearance.

Code information

No UDI. All lots affected.

Distribution pattern

US Nationwide distribution.