THERA PEARL 3-in-1 BREAST THERAPY — Class II medical device recall Z-0784-2013
Terminated recall by Lansinoh Laboratories Inc, reported 2013-02-13, distributed nationwide. The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs ha
| Recall number | Z-0784-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lansinoh Laboratories Inc, Alexandria, VA, United States |
| Recall initiated | 2012-08-14 |
| Classified | 2013-02-04 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 51,472 units |
| Lot numbers | 100/12/01, 108/12/01, 109/12/01, 116/12/01, 149/12/01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0784-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.