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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Apr 21, 2023 Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Oct 28, 2015 rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; ... These sensors were manufactured with incompatible configurations. This could result in sensors th... Class II Masimo Corporation
Sep 30, 2014 Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-li... Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on... Class II Masimo Corporation
Mar 13, 2013 Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories... Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable conn... Class II Masimo Corporation

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.