Z-1632-2020Class II

Merits E604 Pilot Navigator Stairlift -

Name: Z-1632-2020 Merits E604 Pilot Navigator Stairlift -
Creator: Merits Holdings Co. dba Merits Health Products, Inc.
Published: 2020-03-02
License: https://open.fda.gov/license/

Merits Health Products, Inc. / initiated 2020-03-02 / Terminated / root cause: design

FDA source

Merits Holdings Co. dba Merits Health Products, Inc. began a recall of Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs on 2020-03-02. FDA classified it as Class II and gives the reason as "Pinion gear may disengage from track allowing lift to slip or jolt". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1632-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-02
Posted: 2020-04-01
Terminated: 2023-09-18
Recalling firm: Merits Health Products, Inc.
Product: Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Product code: KNO Accessories, Wheelchair
Reason for recall: Pinion gear may disengage from track allowing lift to slip or jolt.
Root cause tag: design
FDA root cause: Device Design
Action: Merits Health Products notified customers on 03/17/2020 via "Medical Device Field Correction E604 Pilot Navigator" letter. The letter identified the affected product and requested the customers to complete the form.
Quantity in commerce: 82 units.
Distribution: US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
Product codes and lots: Model: E60424YLMUB; SN: MU180600588; (01) 04714379292589 (11)190604 (21) MU190600025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1632-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1632-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code KNO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)