Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 8, 2013
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
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 butt…
Masimo Corporation recalled Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicat… - a moderate-severity action.
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicat… was recalled by Masimo Corporation in May 8, 2013. Reason: Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, …. Check the official notice for the remedy. Verify recall #Z-1187-2013 with the FDA Devices before acting.
The recall
Masimo Corporation issued this moderate-severity FDA Devices recall-Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, ….
- Moderate
- severity level
- 43K units
- affected scope
- Class II
- classification
- May 8, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1187-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1187-2013) was formally reported on May 8, 2013, with the manufacturer initiating the action on March 13, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Masimo Corporation is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 42,908 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
42,908 units
Related Recalls
6
3 from same agency
Product description
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1187-2013 |
| Date reported | May 8, 2013 |
| Date initiated | March 13, 2013 |
| Recalling firm | Masimo Corporation |
| Firm location | Irvine, CA |
| Affected scope | 42,908 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1187-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).. Recalled by Masimo Corporation. Units affected: 42,908 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1187-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1187-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 8, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.