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Browse Device Recalls

29 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 29 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 29 FDA device recalls.

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DateProductReasonClassFirm
May 13, 2024 Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... Class II Roche Diabetes Care, Inc.
Mar 9, 2022 RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... Potential for patient data mismatch when using browser "back" button to navigate between patients... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model number... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbe... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number ... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Dec 11, 2019 ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring Syste... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Dec 11, 2019 Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitor... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Dec 11, 2019 Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monit... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RE... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE ME... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SA... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RE... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HC... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SA... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
May 3, 2019 Accu-Chek Connect Diabetes Management App Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to t... Class II Roche Diabetes Care, Inc.
May 7, 2018 Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. ... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
May 7, 2018 Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos... The recalling firm identified four US lots of test strips out of specification. Affected strips s... Class II Roche Diabetes Care, Inc.
May 7, 2018 Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 0... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
Jun 12, 2017 Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 12, 2017 Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 8, 2017 Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... Class II Roche Diabetes Care, Inc.
Jun 8, 2017 Accu-Chek Connect diabetes management software app, Catalog number 0756246200... Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... Class II Roche Diabetes Care, Inc.
Mar 14, 2017 Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for... A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice ... Class II Roche Diabetes Care, Inc.
Dec 20, 2016 Accu-Chek Connect Diabetes Management App iOS and Android: Under certain conditions the affected app versions may disregard historical bolu... Class II Roche Diabetes Care, Inc.
Sep 14, 2016 Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on ... Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect... Class II Roche Diabetes Care, Inc.
Apr 22, 2015 AccuChek Spirit insulin infusion pump. Roche has become aware of an increase of mechanical errors experienced by customers using the Acc... Class II Roche Diabetes Care, Inc.
Apr 22, 2015 AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo S... Roche has become aware of an increase of mechanical errors experienced by customers using the Acc... Class II Roche Diabetes Care, Inc.
Oct 30, 2014 ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to ... Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management a... Class II Roche Diabetes Care, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.