Z-2581-2023Class II

Welch Allyn Connex Spot Monitor

Name: Z-2581-2023 Welch Allyn Connex Spot Monitor
Creator: Baxter Healthcare Corporation
Published: 2023-08-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-08-10 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn Connex Spot Monitor on 2023-08-10. FDA classified it as Class II and gives the reason as "Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2581-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-09-12
Recalling firm: Baxter Healthcare Corporation
Product: Welch Allyn Connex Spot Monitor
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
Root cause tag: design
FDA root cause: Device Design
Action: The consignee recall notification was sent out via email 08/10/2023. The letter instructs the consignee to immediately locate, isolate, and cease all use of the affected product, contact Baxter Customer Service and Technical Support to arrange for return and replacement of the impacted units, acknowledge receipt by responding on the customer portal, and notify other affected customers of the consignee. Affected product will be removed from the field and customers will receive replacement units of the Connex Spot Monitor. Impacted product will be returned to Baxter and will be destroyed per the Return Material Authorization process.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2581-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2581-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-12

Product code MWI

K142356Class IIConnex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc. / cleared 2014-12-19

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)