OVERLOOKED

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Class IIOngoing

Healthmark Industries Co., Inc. recalls Vinyl Instrument Guards

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Healthmark Industries Co., Inc.
Reason
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99943…

Products

  1. 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 GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model Number 09-1-015; 11) VENTED INSTRUMENT GUARD 13/32 X 3/4 - MAROON, Model Number 09-1-016; 12) MAROON VENTED INSTRUMENT GUARD 13/32 X 3/4, Model Number 09-1-016; 13) MAROON VENTED INSTRU GUARD 13/32 X 3/4, Model Number 09-1-016; 14) VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1 - ORANGE, Model Number 09-1-017; 15) ORANGE VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 16) OR VENTED INSTRU GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 17) VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1 - BROWN, Model Number 09-1-018; 18) BROWN VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 19) BROWN VENTED INSTRU GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 20) VENTED INSTRUMENT GUARD 1/8 X 1 X 1 - BLACK, Model Number 09-1-019; 21) BLACK VENTED INSTRUMENT GUARD 1/8 X 1 X 1, Model Number 09-1-019; 22) BLACK VENTED INSTRU GUARD 1/8 X 1 X 1, Model Number 09-1-019; 23) OPAQUE ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 24) OPAQUE COLOR - ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 25) VENTED INSTRUMENT GUARD 1/16 X 3/4 - TRANSPARENT BLUE, Model Number 09-2-011;

    Codes/lots: Model Number 09-1-011, UDI DI 00840113213610, Lot Number 46313; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UQuantity: 12,835,920 unitsRecall no. Z-0188-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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