FDA Device recall Z-0784-2013
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box by Lansinoh Laboratories, citing 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 he….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0784-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-14 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lansinoh Laboratories |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0784-2013%22
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