Z-1690-2017Class II

8500M Handheld Pulse Oximeter

Name: Z-1690-2017 8500M Handheld Pulse Oximeter
Creator: Nonin Medical, Inc
Published: 2016-09-29
License: https://open.fda.gov/license/

Nonin Medical, Inc / initiated 2016-09-29 / Terminated / root cause: manufacturing process

FDA source

Nonin Medical, Inc began a recall of 8500M Handheld Pulse Oximeter on 2016-09-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1690-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2017-03-28
Terminated: 2018-03-12
Recalling firm: Nonin Medical, Inc
Product: 8500M Handheld Pulse Oximeter
Product code: DQA 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were called and sent on 9-29-2016 a Nonin Urgent Medical Device Recal" letter dated 29 September, 2016. The letter described the problem and the product involved in the recall. Additionally, it described the Potential Risk and Required Action. Requested consignees to return the affected units and to forward the contact information if the unit is no longer in their inventory. For questions contact [email protected] or via direct telephone at 763 577 3196.
Quantity in commerce: 15 (11 US; 4 OUS)
Distribution: Distribution in US (MI, NC, OH, NC, VA), and CANADA
Product codes and lots: 502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-28

Product code DQA

K893221Class IIModel 8500 Hand Held Pulse OximeterNonin Medical, Inc. / cleared 1990-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)