Class 2 Device Recall healthmark ProChek

• Date Initiated by Firm: July 29, 2026
• Date Posted: August 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3032-2026
• Recall Event ID: 99537
• Product Classification: Qualitative cleaning process protein indicator - Product Code SDC
• Product: healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
• Code Information: Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
• FEI Number: 1000160387
• Recalling Firm/ Manufacturer: Healthmark Industries Co., Inc.; 18600 Malyn Blvd; Fraser MI 48026-3496
• For Additional Information Contact: Customer 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: Under Investigation by firm
• Action: GETINGE 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 Commerce: 53 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
• Total Product Life Cycle: TPLC 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.