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U.S. Department of Health and Human Services

Class 2 Device Recall healthmark ProChek

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 Class 2 Device Recall healthmark ProCheksee related information
Date Initiated by FirmJuly 29, 2026
Date PostedAugust 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3031-2026
Recall Event ID 99537
Product Classification Qualitative cleaning process protein indicator - Product Code SDC
Producthealthmark ProChek-II, Model Number PT-313, PT-201-12
Code Information 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.
FEI Number 1000160387
Recalling Firm/
Manufacturer		 Healthmark Industries Co., Inc.
18600 Malyn Blvd
Fraser MI 48026-3496
For Additional Information ContactCustomer Service
800-521-6224
Manufacturer Reason
for Recall		Test manufactured with an expired ingredient which may present as either a false negative or positive.
FDA Determined
Cause 2		Under Investigation by firm
ActionGETINGE issued an URGENT MEDICAL DEVICE RECALL/REMOVAL to its consignees on 7/29/2026 via email and telephone. The notice explained the issue, risks to health, and requested the following: "Customer Actions Our records indicate that your facility has received one or more of the affected devices that are affected by this notice. As a result, Healthmark requests that your facility takes the following actions: 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals who need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at HMCS@hmark.com or 800-521-6224 to return your unused affected product or if you have any questions. 4. Please fill out the Customer Response Form using the link or QR code provided below. Getinge has partnered with IQVIA MedTech to coordinate the recall response process."
Quantity in Commerce5090 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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