Medtronic Simplera Sensor Recall: Infection Risk from Loose Cap Label
Medtronic recalls Simplera Sensor model MMT-5100JD1 due to potential infection from cap label not adhering to the sensor. Affected units sold with lot # HG81GLZ and GTIN 20763000649580.
Lower-risk recall
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Contact the company
What happened, in plain English
Medtronic is recalling Simplera Sensor devices with model number MMT-5100JD1 because the cap label might not stick properly, which could lead to infection. This is a safety issue for people using medical devices that require sterile conditions. Read more at govinfonow.com/recall/52327-medtronic-simplera-sensor-recall-infection-risk-from-loose-cap-label.
Source Summary by GovInfoNow · govinfonow.com/recall/52327-medtronic-simplera-sensor-recall-infection-risk-from-loose-cap-label · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0033-2026
Cite this page
“Medtronic Simplera Sensor Recall: Infection Risk from Loose Cap Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52327-medtronic-simplera-sensor-recall-infection-risk-from-loose-cap-label. Based on FDA recall #Z-0033-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0033-2026%22&limit=1).
Why it’s dangerous
The cap label on the sensor may not stay securely attached, which can compromise the sensor's sterility. This increases the risk of infection because medical devices need to be kept sterile to prevent contamination.
Who’s affected
People with Medtronic Simplera Sensor devices (model MMT-5100JD1) who use the device for medical purposes are most at risk. The recall affects specific units sold with lot number HG81GLZ and GTIN 20763000649580.
How to tell if you have this one
Check for the model number MMT-5100JD1 on the device. Affected units were sold with lot number HG81GLZ and GTIN 20763000649580.
- Brand
Medtronic- Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1- Category
Medical device
What to do — step by step
Check Device Label
Look for the model number MMT-5100JD1 and lot number HG81GLZ on the device.
How this recall unfolded
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0033-2026 (May 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0033-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.