Facility

Industrial Vallera de Mexicali, S. A. de C. V.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004415095
Establishment type	Manufacture Medical Device
Location	Calzada del Oro no. 2001 Mexicali Mexico, MX 21600
Registration status	Active · expires 2026
Parent company	MASIMO CORPORATION (owner-operator 9031881)
Brand names	rainbow SET IntelliVue Module; CareScape SpO2 - Masimo

Activity by year

Recalls (6)

Devices registered here (1)

Oximeter
Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700

Recalls & enforcement

Class IIOngoing2026-02-20
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay …
Class IIOngoing2024-02-15
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIOngoing2023-04-21
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class IITerminated2015-10-28
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
Class IITerminated2014-09-30
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 valu…
Class IITerminated2013-03-13
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Industrial Vallera de Mexicali, S. A. de C. V. (FEI 3004415095) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004415095-industrial-vallera-de-mexicali-s-a-de-c-/

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