Z-0115-2014Class II

Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is...

Name: Z-0115-2014 Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is...
Creator: S.a.e. Afikim
Published: 2013-09-27
License: https://open.fda.gov/license/

Afikim Electric Vehicles (S.A.E. AFIKIM) / initiated 2013-09-27 / Terminated / root cause: manufacturing process

FDA source

S.A.E. AFIKIM began a recall of Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly... on 2013-09-27. FDA classified it as Class II and gives the reason as "Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which...". 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-0115-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Posted: 2013-10-30
Terminated: 2014-07-23
Recalling firm: Afikim Electric Vehicles (S.A.E. AFIKIM)
Product: Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
Product code: INI Vehicle, Motorized 3-Wheeled
Reason for recall: Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Afikim Electric Vehicles sent an URGENT: MEDICAL DEVICE RECALL letter, dated September 27, 2013, to all affected customers and distributors. . Customers are advised to remove the ignition key and contact Afikim Electric Vehicles via telephone Monday through Friday at 1-800-809-3010 between the hours of 9AM and 5PM (EST). Consumers may also contact the company via e-mail at [email protected]. Customers are instructed to return the Recall Response Form by fax it to 800-466-1171 or email to [email protected]. Consumers should report any adverse event or quality problems to FDA's MedWatch Adverse Event Reporting program either by online, fax, or regular mail.
Quantity in commerce: 69 units
Distribution: Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin.
Product codes and lots: Serial Numbers: 10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172, 12490173, 12490174, 12490175, 12490176, 12490177, 12490178, 12490179, 12490180, 12490181, 12490182, 12490183, 12490184, 12490185, 12490186, 12490187, 12490188, 12490189, 12490190, 12490191, 12490192, and 12490193.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0115-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30

Product code INI

K102304Class IIBreeze C Model C (3W), Breeze C (4W)Afikim Electric Vehicles / cleared 2011-01-07

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)