Pinook Micro Massager Recalled for Lack of FDA Approval
Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. As no specific injuries or illnesses are reported in the source text, it falls under the Moderate category for regulatory non-compliance without reported harm.
Plain-English summary
Pinook-Usa is recalling 28,994 units of the Pinook Micro Massager, including Micro and Mini models. The product is used to strengthen abdominal muscles and was distributed nationwide in the United States, including Puerto Rico and Guam, as well as in Canada.
The recall was initiated because the firm failed to submit a premarket submission and gain approval of the medical device from the FDA. This regulatory failure means the device was marketed without the required safety and effectiveness review.
Consumers who purchased these devices should stop using them immediately. The recall covers all lots of the product.
The recalled product
- Product
- Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
- Manufacturer
- Pinook-Usa
- Affected units
- 28,994
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 (1)
- ALL LOTS
Distribution
Part of a larger recall action
This product is one of 2 recalled by Pinook-Usa under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Pinook-Usa
See all →- ModeratePinook Mini Massager Recalled for Failure to Submit Premarket Approval
FDA (Devices) · 2013-11-13
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