Healthmark Industries recall: Healthmark ProChek-II and 1 more product
Healthmark Industries Co., Inc. is recalling Healthmark ProChek-II and 1 more product – 5090 units; 53 units. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on July 29, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Healthmark ProChek-II and 1 more product |
| Brand | Healthmark Industries |
| Company | Healthmark Industries Co., Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 29, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 5090 units; 53 units |
| Recall ID | 99537 |
Recalled products (2)
- healthmark ProChek-II, Model Number PT-313, PT-201-12
- FDA recall number
- Z-3031-2026
- Codes, lots and dates
- PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122.
- Quantity
- 5090 units
- Classification
- Class II
- healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
- FDA recall number
- Z-3032-2026
- Codes, lots and dates
- Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
- Quantity
- 53 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99537
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Fraser, MI, United States
Why it was recalled
The reason the FDA lists: “Test manufactured with an expired ingredient which may present as either a false negative or positive.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99537, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Healthmark Industries Healthmark ProChek-II recalled?
Yes. Healthmark Industries Co., Inc. recalled it on July 29, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Test manufactured with an expired ingredient which may present as either a false negative or positive.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.