FDA Medical Device Recalls (openFDA)
Karman Healthcare Inc: Karma Flexx Wheelchair Manual Wheelchair.
- Recall number
- Z-1025-2016
- Recalling firm
- Karman Healthcare Inc
- Product
- Karma Flexx Wheelchair Manual Wheelchair.
- Status
- Terminated
- Initiated
- 2016-01-27
- Posted
- not on file
- Terminated
- 2016-06-29
- Reason
- 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
- 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 edward@karmanhealthcare.com. 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
- 35
- Distribution
- U.S. distribution to the following states -- WA, CA, NY, and TX.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K002167"]
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 1000306460
- Firm city
- City of Industry
- Firm state
- CA
- 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