Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE
Medical device recall Z-0188-2027. Published in FDA’s Enforcement Report on Oct 21, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 21, 2026. Copied from openFDA on Oct 27, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 12,835,920 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Which ones are recalled?
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;
12,835,920 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 1,997 characters
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, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 85979; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 88504; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 92954; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 95456; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 96593; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 154671; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 166797;…
FDA’s list runs to 337,123 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 7, 2026.
- FDA classified it on Oct 15, 2026.
- FDA’s Enforcement Report published it on Oct 21, 2026.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Who is recalling it?
- Healthmark Industries Co., Inc., of Fraser, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 337,123 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 27, 2026 and checked Oct 27, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 27, 2026.