Z-1025-2016Class II

Karma Flexx Wheelchair Manual Wheelchair

Name: Z-1025-2016 Karma Flexx Wheelchair Manual Wheelchair
Creator: Karman Healthcare Inc
Published: 2016-01-27
License: https://open.fda.gov/license/

Karman Healthcare Inc / initiated 2016-01-27 / Terminated / root cause: manufacturing process

FDA source

Karman Healthcare Inc began a recall of Karma Flexx Wheelchair Manual Wheelchair on 2016-01-27. FDA classified it as Class II and gives the reason as "Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets". 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-1025-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-27
Posted: 2016-02-27
Terminated: 2016-06-29
Recalling firm: Karman Healthcare Inc
Product: Karma Flexx Wheelchair Manual Wheelchair.
Product code: IOR Wheelchair, Mechanical
Reason for recall: Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 01/27/16 the firm sent out customer notification letters. In the letter customers were informed that the firm was conducting a product update for original purchasers of KM8522. Customers were provided the following procedures for the product update: 1. Completed and signed notification must be returned to Karman Healthcare via fax at (626)-581-2335, or e-mail to [email protected]. 2. Following the received frame, customers may install their current wheels, and footrest onto the newly updated frame. Kindly package the used frame into the carton in the same manner the new carton was shipped. 3. A prepaid return shipping label is included with the letter, which customers may use to return the carton; or contact the firm's customer service line at (800)-805-2762 to have a trained representative schedule a pickup at no charge.
Quantity in commerce: 35
Distribution: U.S. distribution to the following states -- WA, CA, NY, and TX.
Product codes and lots: Item # 935-0245H6 Flexx (KM852216) Serial # TM14-A03982-TM14-A03991 Item # 935-0246H6 Flexx (KM852218) Serial # TM14-A03992-TM14-A04012 Item # 935-0247H6 Flexx (KM852220) Serial # TM14-A4013-TM14-A04017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1025-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1025-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-02-27

Product code IOR

K002167Class IKarman WheelchairKarman Healthcare, Inc. / cleared 2000-08-25

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)