Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
THERA PEARL 3-in-1 BREAST THERAPY Recalled by Lansinoh Laboratories Inc Due to The Spanish translation on the Instructions for Use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lansinoh Laboratories Inc directly.
Affected Products
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.
Quantity: 51,472 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lansinoh Laboratories Inc
Lansinoh Laboratories Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report