Lower risk Medical device recall · FDA · Published September 7, 2026

Healthmark Industries Recall: Model Numbers 09-1-013 and 09-1-014

Healthmark Industries Co., Inc. is recalling 12,835,920 units of medical devices with model numbers 09-1-013 and 09-1-014 due to potential safety issues. Affected lots are listed below.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0188-2027Medical device Healthmark Industries ›

Lower-risk recall

Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

✎ GovInfoNow plain-language explainer

Healthmark Industries Co., Inc. has initiated a Class II recall affecting 12,835,920 units of medical devices with model numbers 09-1-013 and 09-1-014. The UDI DI for these products is 00840113213474 (Model 09-1-013) and 00840113213573 (Model 09-1-014). The recall involves worldwide distribution, including the US, Japan, Australia, Canada, and several other countries. Consumers should check their device lot numbers against the list below. Read more at govinfonow.com/recall/1764694-healthmark-industries-co-inc-recalls-vinyl-instrument-guards-labeled-as.

Source Summary by GovInfoNow · govinfonow.com/recall/1764694-healthmark-industries-co-inc-recalls-vinyl-instrument-guards-labeled-as · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0188-2027

Cite this page

“Healthmark Industries Recall: Model Numbers 09-1-013 and 09-1-014.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764694-healthmark-industries-co-inc-recalls-vinyl-instrument-guards-labeled-as. Based on FDA recall #Z-0188-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2027%22&limit=1).

Healthmark Industries Co., Inc. has initiated a voluntary recall of specific lots of its ProChek-II and related medical devices due to potential false test results, lack of FDA clearance, and contamination risks.

How to tell if you have it

Model Number: 09-7-012
UDI DI: 00840113215065
Lot Numbers: 100000532, 3000548286, 3000548459, 181766, 43147, 332305, 387477, 166793, 308560

The hazard

The ProChek-II devices were manufactured with an expired ingredient, which may result in false negative or false positive test results. Additionally, other recalled items such as Mesh Tip Protectors lack FDA clearance, and Pre-filled Water Syringes are linked to contamination risks during endoscope surveillance monitoring.

Context

This recall is part of a broader pattern of quality control issues at Healthmark Industries Co., Inc., which has had three other recalls on record since May 2025. Similar recent industry recalls include Medline's DYNJ Series devices and Edermy PIE PAK models due to lack of 510(k) clearance.

How to tell if you have this one

Check your device for the following Model Numbers and Lot Numbers:

Brand
Healthmark Industries
Category
Medical device

Based on the official FDA remedy

What to do — step by step

1
Identify your device model number (09-1-013 or 09-1-014).
2
Check the Lot Number on your device against the lists below.
3
If your device is part of this recall, stop using it immediately and contact Healthmark Industries or a healthcare professional for instructions on return or replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Sep 7, 2026Firm started the recall
Oct 15, 2026FDA classified it Class II
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the scope of the recall?

The recall affects 12,835,920 units distributed worldwide, including the US, 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.

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Link to this recall

<a href="https://govinfonow.com/recall/1764694-healthmark-industries-co-inc-recalls-vinyl-instrument-guards-labeled-as">Healthmark Industries Recall: Model Numbers 09-1-013 and 09-1-014 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0188-2027 (September 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0188-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.