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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Simplera Sensor

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 Class 2 Device Recall Medtronic, Simplera Sensorsee related information
Date Initiated by FirmMay 07, 2025
Date PostedOctober 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0033-2026
Recall Event ID 96745
PMA NumberP160007 
Product Classification Sensor, glucose, invasive - Product Code MDS
ProductMedtronic, Simplera Sensor, REF: MMT-5100JD1
Code Information Lot # HG81GLZ/ GTIN: 20763000649580
FEI Number 3003166194
Recalling Firm/
Manufacturer		 Medtronic MiniMed, Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactMedtronic 24-Hr. Tech Support
1800-646-4633 Ext. 1
Manufacturer Reason
for Recall		The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA Determined
Cause 2		Process design
ActionOn May 7, 2025, Medtronic issued a "Urgent Field Safety Notice" to affected consignees. Medtronic asked consignees to take the following actions: 1. Verify if the sensors you currently have are from the impacted lot. 2. If you have a Simplera" sensor from the impacted lot, do not use this Simplera" sensor and dispose of it according to local regulations. 3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.
Quantity in Commerce1,440 units
DistributionUS: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
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.
PMA DatabasePMAs with Product Code = MDS
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