Z-1989-2009

Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a...

Name: Z-1989-2009 Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a...
Creator: Breg Inc, An Orthofix Company
Published: 2009-06-18
License: https://open.fda.gov/license/

Breg Inc / initiated 2009-06-18 / Terminated / root cause: manufacturing process

FDA source

Breg Inc, An Orthofix Company began a recall of Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is... on 2009-06-18. The reason FDA records is "Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip". 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-1989-2009
Status: Terminated
Initiated: 2009-06-18
Posted: 2009-09-04
Terminated: 2011-03-28
Recalling firm: Breg Inc
Product: Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low voltage power to the Kodiak unit. The power supply is not used with other Polar Care models such as PC300 and PC500.
Product code: ILO Pack, Hot Or Cold, Water Circulating
Reason for recall: Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent: Medical Device Recall Notification was sent to customers on June 18, 2009. FOR USERS: Customers are advised to immediately open all unused Kodiak cold therapy units and inspect the lot code of the Power Supply included with the Kodiak unit. If the lot code is 3508, 3908, 4308, or 4808, then remove the power supply, cut the cord using scissors and discard. Call Breg Customer Service for a replacement: 1-800-321-0607. Complete and return the response form ASAP. FOR DISTRIBUTORS: Send Breg your distribution information, including contact and quantities. Breg will notify your customers of the recall directly.
Quantity in commerce: 20,439
Distribution: Worldwide Distribution
Product codes and lots: Lots 3508, 3908, 4308, and 4808.

Product code ILO

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)