Lansinoh Thera Pearl Breast Therapy Hot and Cold Packs Recalled for Overheating Risk
Lansinoh is recalling Thera Pearl 3-in-1 Breast Therapy packs because incorrect Spanish heating instructions may cause the product to overheat.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from overheating) where no injuries have been reported yet, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Lansinoh Laboratories Inc is recalling 51,472 units of the Thera Pearl 3-in-1 Breast Therapy, a reusable therapeutic hot and cold pack used for breast feeding-related pain and swelling. The recall is due to incorrect heating instructions on the Spanish translation of the Instructions for Use (IFU) insert and product package, which could cause the product to overheat.
The affected units were distributed nationwide, including in Texas, California, New Jersey, New York, South Dakota, Rhode Island, West Virginia, Illinois, Pennsylvania, North Carolina, and Minnesota. The specific lot numbers involved are 100/12/01, 116/12/01, 108/12/01, 109/12/01, and 149/12/01.
Consumers should stop using the product and contact Lansinoh Laboratories Inc for further instructions or a refund.
The recalled product
- 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…
- Manufacturer
- Lansinoh Laboratories Inc
- Hazard
- Affected units
- 51,472
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers 100/12/01
- 116/12/01
- 108/12/01
- 109/12/01
- 149/12/01
Distribution
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