Z-0784-2013Class II

THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy...

Name: Z-0784-2013 THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy...
Creator: Lansinoh Laboratories Inc
Published: 2012-08-14
License: https://open.fda.gov/license/

Lansinoh Laboratories Inc / initiated 2012-08-14 / Terminated / root cause: labeling and UDI

FDA source

Lansinoh Laboratories Inc began a recall of THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for... on 2012-08-14. FDA classified it as Class II and gives the reason as "The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat". 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-0784-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-14
Posted: 2013-02-04
Terminated: 2013-03-08
Recalling firm: Lansinoh Laboratories Inc
Product: THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
Product code: IME Pack, Hot Or Cold, Reusable
Reason for recall: The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.
Quantity in commerce: 51,472 units
Distribution: Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
Product codes and lots: Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0784-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code IME

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)