Lansinoh Laboratories Inc: Medical Device Recall in 2013 - (Recall #: Z-0784-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 14, 2012

Date Posted: February 13, 2013

Recall Number: Z-0784-2013

Event ID: 63390

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.

Status: Terminated

Product Quantity: 51,472 units

Code Information:

Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01

Distribution Pattern:

Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.

Voluntary or Mandated:

Voluntary: Firm initiated