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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2027%22

Class II recall Z-0188-2027: Healthmark Industries Co., Inc.

Q: How to monitor Class II recall Z-0188-2027: Healthmark Industries Co., Inc. and peer other records

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Class II recall Z-0188-2027: Healthmark Industries Co., Inc. (Michigan): Healthmark Industries Co., Inc. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 3 related MI FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0188-2027
Recalling firm	Healthmark Industries Co., Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT G
Reason	Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Quantity	12,835,920 units
Distribution	Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
Recall initiated	2026-09-07
Reported	2026-10-21
Firm location	Fraser, MI, United States
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-21
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-0188-2027: Healthmark Industries Co., Inc. and 4 Michigan peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Michigan FDAPulse records like this one: 4
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Michigan peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 14 days ago.

What is the FDAPulse record for Class II recall Z-0188-2027: Healthmark Industries Co., Inc. in Michigan?

Class II device recall Z-0188-2027 by Healthmark Industries Co., Inc.: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

How does Class II recall Z-0188-2027: Healthmark Industries Co., Inc. compare to other Michigan FDAPulse records?

It is fresh: dated 14 days ago, inside the window where early outreach matters most.

Class II recall Z-0188-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0188-2027	MI	2026-10-21
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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