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Masimo Waited Six Months to Recall Faulty Devices

Wearables maker provides no explanation for recall delay which has resulted in a federal probe.

March 13, 2024

On February 1, 2023 Masimo Corp. (MASI), a maker of non-invasive patient monitoring devices, voluntarily recalled some select Pulse Oximeters and Temperature Devices that unexpectedly shut down and turn back on.

Masimo knew of trouble at least six months before announcing the recall— and maybe longer. The company acknowledges it had decided to recall the devices as early as August 2023 but provides no explanation for the delay in actually issuing the recall in February of the following year.

On February 21, 2024, seven days after the recall was announced, Masimo revealed it received a subpoena from the Department of Justice (DOJ) seeking documents and information related to the company’s Rad-G and Rad-97 products, including information relating to complaints surrounding the products and the company’s decision to recall the Rad-G.

in its latest annual report, Masimo provided no explanation for the delay:

“We are investigating the reasons for the delay between August 2023 and February 2024 when the recall was initiated.”

While not quantifying the financial impact, Masimo did say it may expend “significant financial and managerial resources” responding to the subpoena and future requests for information.

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