Recall StatusOpen, Classified
Date Initiated2026-04-23
Product Quantity1775 units
Reason for Recall
Temperature probe devices lack FDA clearance.
Firm Action
On April 23, 2026 Covidien (subsidiary of Medtronic) issued a Urgent Medical Device Recall Notification to affected consignees via USPS. Covidien ask consignees to take the following actions:
1. Quarantine all unused product from the affected lots.
2. Return all unused product(s) from the affected lots in your inventory to Medtronic as described in the Customer Confirmation Form.
3. Share this notice with all relevant personnel within your organization, and with any organization to which the potentially affected product from the specified lots has been transferred or distributed.
4. Please complete and return the enclosed Customer Confirmation Form to
[email protected] even if you do not have unused inventory.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.