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FDA Medical Device Recalls (openFDA)

Merits Holdings Co. dba Merits Health Products, Inc.: Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

Recall number
Z-1632-2020
Recalling firm
Merits Holdings Co. dba Merits Health Products, Inc.
Product
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Status
Terminated
Initiated
2020-03-02
Posted
not on file
Terminated
2023-09-18
Reason
Pinion gear may disengage from track allowing lift to slip or jolt.
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
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.
Lot, serial or model codes
Model: E60424YLMUB; SN: MU180600588; (01) 04714379292589 (11)190604 (21) MU190600025.
510(k) numbers
not on file
PMA numbers
not on file
Product code
KNO
Firm FEI
1000221992
Firm city
Fort Myers
Firm state
FL
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

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