Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 5, 2017
8500M Handheld Pulse Oximeter
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may no…
Nonin Medical, Inc recalled 8500M Handheld Pulse Oximeter - a moderate-severity action.
8500M Handheld Pulse Oximeter was recalled by Nonin Medical, Inc in April 5, 2017. Reason: Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 850…. Check the official notice for the remedy. Verify recall #Z-1690-2017 with the FDA Devices before acting.
The recall
Nonin Medical, Inc issued this moderate-severity FDA Devices recall-Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 850….
- Moderate
- severity level
- Class II
- classification
- April 5, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1690-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1690-2017) was formally reported on April 5, 2017, with the manufacturer initiating the action on September 29, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Nonin Medical, Inc is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 15 (11 US; 4 OUS).
The documented reason for this recall is: Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board… Distribution data in the federal record shows the product reached: Distribution in US (MI, NC, OH, NC, VA), and CANADA. 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
15 (11 US; 4 OUS)
Related Recalls
6
3 from same agency
Product description
8500M Handheld Pulse Oximeter
Reason for recall
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1690-2017 |
| Date reported | April 5, 2017 |
| Date initiated | September 29, 2016 |
| Recalling firm | Nonin Medical, Inc |
| Firm location | Plymouth, MN |
| Affected scope | 15 (11 US; 4 OUS) |
| Distribution | Distribution in US (MI, NC, OH, NC, VA), and CANADA |
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-1690-2017) 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? ▼
8500M Handheld Pulse Oximeter. Recalled by Nonin Medical, Inc. Units affected: 15 (11 US; 4 OUS).
Why was this product recalled? ▼
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1690-2017.
Where was the recalled product distributed? ▼
Distribution: Distribution in US (MI, NC, OH, NC, VA), and CANADA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1690-2017) 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 April 5, 2017. 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.