FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Recall number
- Z-0033-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Status
- Open, Classified
- Initiated
- 2025-05-07
- Posted
- 2025-10-02
- Terminated
- not on file
- Reason
- The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
- Root cause
- Process design
- Action
- On 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
- 1,440 units
- Distribution
- US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
- Lot, serial or model codes
- Lot # HG81GLZ/ GTIN: 20763000649580
- 510(k) numbers
- not on file
- PMA numbers
- ["P160007"]
- Product code
- MDS
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28