Healthmark Industries Co., Inc. recalls Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED…
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Healthmark Industries
- 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…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Following a Chromium-based web-browser, report and displayed images may not match.
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