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FDA Medical Device Recalls (openFDA)

Medical Depot Inc.: Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

Recall number
Z-2354-2024
Recalling firm
Medical Depot Inc.
Product
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
Status
Open, Classified
Initiated
2024-06-14
Posted
2024-07-12
Terminated
not on file
Reason
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Root cause
Process control
Action
Drive DeVilbiss Healthcare ( Drive ) issued Urgent Medical Device Recall letter on 6/14/24 to Distributors and End-Users via email. Letter states reason for recall, health risk and action to take: Please take the following three actions immediately: 1)Identify any inventory in your possession of 791BL and 791RD Nitro" Glide Knee Walkers containing serial numbers beginning with 21S, and ensure that they are placed in a location that will prevent sale or rental to an end user. 2) Go to https://www.recallrtr.com/kneewalker and enter your Unique Customer Code, located on the first page of this notice, directly below your address in bold type. Using that code on the website, you will be able to: a. Confirm the quantity of affected units in your possession (i.e., units that contain a serial number beginning with 21S); b. Request postage-paid mailing labels and packing material to return the affected units; c. Order replacement products; and d. Fill out a web form to acknowledge receipt of and compliance with the recall. If you experience any issues with the website or wish to communicate via phone, Drive has established a dedicated Customer Service phone number, (877) 206-1171, which will be available Monday through Friday, from 7:30 a.m. to 5:00 p.m. Central Time. You can also contact us via email regarding this recall at kneewalker@realtimeresults.net. 3) Please contact any customer/end user who purchased or rented an affected unit and provide them notice of and instructions for compliance with the recall. The recall website will also be enabled to assist end-users with registering for the recall, returning their affected unit, and receiving a replacement of the unit. On the website, you will also have the option to provide your customer list so that notification of end-users may be performed on your behalf.
Quantity
875 units
Distribution
Nationwide Foreign: Canada
Lot, serial or model codes
UPC: 822383019093 (791BL) All serial numbers beginning with 21S
510(k) numbers
not on file
PMA numbers
not on file
Product code
ITJ
Firm FEI
3002997602
Firm city
Port Washington
Firm state
NY
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

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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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