FDA recall, , Moderate risk
Healthmark Vinyl Instrument Guards
Vinyl Instrument Guards have labeling that is not compliant with regulations and updated sterilization instructions.
Summary by Recall Canary from the FDA notice
What happened
Healthmark Industries Co., Inc. is recalling Vinyl Instrument Guards, labeled with model numbers 09-1-011 through 09-2-011, because the labeling is not compliant with 21 CFR 801 and the steam sterilization IFU has been updated. The recall began September 7, 2026, and was added to the FDA's Enforcement Report on October 15, 2026.
The product was distributed nationwide and worldwide, including 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 the United Kingdom. The recall affects a quantity of units, and the FDA classified the recall on October 15, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 40 of 47 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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;- UDI-DI
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Recall details
- Company began the recall
- Sold in
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.
- Company
- Healthmark Industries Co., Inc.
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99943
- Recall number
- Z-0188-2027
- Quantity recalled
- 12,835,920 units
All recalls from Healthmark Industries Co., Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
