Z-1353-2021Class II

Drop Arm Versamode"

Name: Z-1353-2021 Drop Arm Versamode"
Creator: Gf Health Products
Published: 2021-03-24
License: https://open.fda.gov/license/

GF Health Products, Inc. / initiated 2021-03-24 / Terminated / root cause: manufacturing process

FDA source

Gf Health Products began a recall of Drop Arm Versamode" on 2021-03-24. FDA classified it as Class II and gives the reason as "The front casters on the 6810A Lumex Drop Arm Versamode are incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1353-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-24
Posted: 2021-04-05
Terminated: 2023-05-01
Recalling firm: GF Health Products, Inc.
Product: Drop Arm Versamode"
Product code: ILS Adaptor, Hygiene
Reason for recall: The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Recall notification letter titled, "URGENT CORRECTION AND REMOVAL" was sent to consignees on 03/24/2021 via FedEx priority. The consignees were instructed to: "The replacement of the front casters is required to ensure proper operation of the Versamode, and to eliminate any potential safety concern. 1. Contact GF Health Products at 1-888-974-4347 or [email protected] within ten (10) business days from receipt of this notification to schedule your front caster replacement order. Replacement front casters will be provided at NO CHARGE for Versamodes with lot number BMW316BS. 2. Upon receipt of the replacement casters, follow the enclosed instructions Replacing Your Lumex Drop Arm Versamode Front Casters. (Attachment 1) 3. Dispose of the incorrect, replaced casters in accordance with Federal, State, or Local regulations. 4. Fill out and sign the Certification of Replacement Agreement. (Attachment 2) 5. Return the completed Certification of Replacement Agreement to: [email protected] or Fax: 770-368-3333."
Quantity in commerce: 66 units
Distribution: Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.
Product codes and lots: Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1353-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1353-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-05

Product code ILS

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)