Roche Diabetes Care, Inc. recalls
Every recall we track for Roche Diabetes Care, Inc. — 23 in all, from 2017–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Roche Diabetes Care, Inc. peaked in 2019 (10); 23 since 2017.
All FDA recall records for Roche Diabetes Care, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 3 | 0 | 4 |
| 2018 | 0 | 0 | 3 | 0 | 3 |
| 2019 | 0 | 0 | 4 | 6 | 10 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 3 | 0 | 4 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Roche Diabetes Care, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Roche Diabetes Care, Inc. recalls
10 shown- Use cautionMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip,
Roche recalls Accu-Chek Guide (SC) Kit due to potential incorrect glucose unit display (mmol/L instead of mg/dL), risking mismanagement of diabetes and health complications.
RocheMay 13, 2024 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software
Roche Diabetes Care recalls software version 2.5.2 (material number 08888353001) due to potential patient data mismatch when using browser back button. This web application was manufactured in November 2021.
Roche Diabetes CareMar 9, 2022 - Use cautionMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Roche recalls Accu-Chek Performa test strips because vials may open during shipping, risking humidity damage and inaccurate blood glucose readings.
Accu-ChekJul 28, 2021 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Roche recalls Accu-Chek Aviva Plus Health Network Strips (Catalog 06908349001) due to potential inability to dose test strips, risking delayed blood glucose treatment.
Roche Diabetes CareDec 11, 2019 - UnratedMedical device
Roche Diabetes Care, Inc. recalls Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The
Roche recalls Accu-Chek Guide Blood Glucose Monitoring System model 08453063001 due to potential power issues. Affected units have serial numbers below XXX11000001. No remedy specified in recall notice.
RocheSep 30, 2019 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Connect Diabetes Management App
Roche recalls Accu-Chek Connect app version 2.1.6.3 for Android 8.0+ users who can't transfer meter values. Fix available via app update.
RocheMay 3, 2019 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek
Roche recalls Accu-Chek Performa test strips that may cause inaccurate blood glucose readings, leading to incorrect health decisions. Affected lots include 476605. Consumers should check their test strip lot numbers.
RocheMay 7, 2018 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be
Roche recalls Accu-Chek Aviva II meters with damaged capacitors that may cause short battery life or failure to turn on. Affected units have specific serial numbers.
RocheJun 12, 2017 - Use cautionMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number
Roche recalls specific versions of Accu-Chek Connect Diabetes Management App due to software bugs that may cause incorrect blood glucose readings or insulin dosing calculations.
RocheJun 8, 2017 - Lower riskMedical device
Roche Diabetes Care, Inc. recalls Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog
Roche recalls Accu-Chek Connect diabetes app versions with rare timer error affecting insulin dosing advice. Users may need to restart app after pairing meter for first time.
RocheJun 8, 2017
Roche Diabetes Care, Inc. recall questions
How many recalls has Roche Diabetes Care, Inc. had?
23 recalls from Roche Diabetes Care, Inc. are on record with U.S. safety agencies, from 2017–2024.
What is the most recent Roche Diabetes Care, Inc. recall?
Roche Diabetes Care, Inc. recalls Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip,, dated May 13, 2024. Every Roche Diabetes Care, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Roche Diabetes Care, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Roche Diabetes Care, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.