FDA Medical Device Recalls (openFDA)
Nonin Medical, Inc: 8500M Handheld Pulse Oximeter
- Recall number
- Z-1690-2017
- Recalling firm
- Nonin Medical, Inc
- Product
- 8500M Handheld Pulse Oximeter
- Status
- Terminated
- Initiated
- 2016-09-29
- Posted
- not on file
- Terminated
- 2018-03-12
- Reason
- 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
- 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 Kim.Aves@nonin.com or via direct telephone at 763 577 3196.
- Quantity
- 15 (11 US; 4 OUS)
- Distribution
- Distribution in US (MI, NC, OH, NC, VA), and CANADA
- Lot, serial or model codes
- 502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090
- 510(k) numbers
- ["K893221"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2183646
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28