Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 19, 2014
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
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 measure…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Masimo Corporation recalled Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable tha… - a moderate-severity action.
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable tha… was recalled by Masimo Corporation in November 19, 2014. Reason: Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance…. Check the official notice for the remedy. Verify recall #Z-0213-2015 with the FDA Devices before acting.
The recall
Masimo Corporation issued this moderate-severity FDA Devices recall-Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance….
- Moderate
- severity level
- 22K units
- affected scope
- Class II
- classification
- November 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0213-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0213-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on September 30, 2014. 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 21,754 units (21,222) in the U.S. and Puerto Rico).
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Nethe…. 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
21,754 units (21,222) in the U.S. and Puerto Rico)
Related Recalls
6
3 from same agency
Product description
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Reason for recall
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 value is measured, a low SpO2 value would be displayed on the monitoring device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0213-2015 |
| Date reported | November 19, 2014 |
| Date initiated | September 30, 2014 |
| Recalling firm | Masimo Corporation |
| Firm location | Irvine, CA |
| Affected scope | 21,754 units (21,222) in the U.S. and Puerto Rico) |
| Distribution | Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Port… |
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-0213-2015) 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? ▼
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.. Recalled by Masimo Corporation. Units affected: 21,754 units (21,222) in the U.S. and Puerto Rico).
Why was this product recalled? ▼
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 value is measured, a low SpO2 value would be displayed on the monitoring device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0213-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0213-2015) 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 November 19, 2014. 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.