Class 2 Device Recall Physitemp MTD

• Date Initiated by Firm: September 28, 2026
• Date Posted: November 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0404-2027
• Recall Event ID: 99935
• Product Classification: Probe - Product Code HXB
• Product: Physitemp MT-D REF: MT-D
• Code Information: All lot codes distributed between January 19, 2024 through January 19, 2026.
• FEI Number: 2242483
• Recalling Firm/ Manufacturer: Physitemp Instruments, LLC; 189 Sargeant Ave; Clifton NJ 07013-1933
• For Additional Information Contact: Michele Cantwell; +1-973-7795577 Ext. 117
• Manufacturer Reason for Recall: Temperature monitors and associated probes have not been reviewed for safety and effectiveness for intended use.
• FDA Determined Cause: No Marketing Application
• Action: Between the dates of September 28, 2026 - October 7, 2026, through Physitemp Instruments, LLC issued a Urgent: Medical Device Correction notification via email. Physitemp ask consignees to take the following actions: 1. Review all internal equipment records to identify any locations or departments where these devices are currently in use. 2. Notify all relevant laboratory personnel that these devices are designated ARUO and must be used solely for animal research and general non-human laboratory purposes. 3. TH-5 and TH-8 - Apply the enclosed ARUO label directly to the device in a clearly visible location that can be readily seen by any user prior to operation. The label must remain affixed to the device at all times and must not be removed, covered, or obscured. 4. For Probes (RET-1, ESO-1, OT-1, SST-1, SST-2, and MT-D Series): Enclosed with this notification is an updated ARUO Instructions for Use (IFU) insert. Please immediately distribute this IFU insert to all research, engineering, and laboratory personnel operating or handling these probes. 5. Discard Legacy Documentation: Please immediately destroy and discard all older, legacy versions of Instructions for Use, user guides, or marketing product inserts for these monitors and probes. 6. Assess current use: If your firm is using these devices for any human clinical purpose including clinical testing, diagnostic use, or any application informing human patient care use must be discontinued immediately. 7. Secondary Notification: If these devices have been further distributed or transferred to another facility, please ensure a copy of this communication along with ARUO label template is provided to that facility and applicable personnel. 8. Acknowledgment: Please sign and return the enclosed acknowledgment form via mail or email to yalcantara@physitemp.com within 30 days to verify your receipt of this administrative documentation update.
• Quantity in Commerce: 36 units
• Distribution: Worldwide - US Nationwide distribution in the states of AR, MA, CA, PA, NY, IN, MD, KS, FL, LA, WA, WI, FL, CT, VA, OH, TX, MN, GA, UT and the countries of Japan, Canada, Australia, China, France, Sweden, England.
• 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.