Z-0616-2013Class II

Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red)...

Name: Z-0616-2013 Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red)...
Creator: Brookstone Company, Inc.
Published: 2012-11-02
License: https://open.fda.gov/license/

Brookstone Company, Inc. / initiated 2012-11-02 / Terminated / root cause: labeling and UDI

FDA source

Brookstone Company, Inc. began a recall of Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The... on 2012-11-02. FDA classified it as Class II and gives the reason as "Additional Warning Statement to prevent burns to the skin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0616-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Posted: 2012-12-27
Terminated: 2013-06-13
Recalling firm: Brookstone Company, Inc.
Product: Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.
Reason for recall: Additional Warning Statement to prevent burns to the skin
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Brookstone sent a "MEDICAL DEVICE CORRECTION" letter dated December 10, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Recall Information is on the website link from the homepage, www. Brookstone.com. Recall posted: http://www.brookstone.com/recall-information. Questions call Brookstone Customer Care at 800.846.3000 or visit any Brookstone Store.
Quantity in commerce: 109,956 units
Distribution: Nationwide Distribution.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0616-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0616-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)