CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report
Pinook Mini Massager recalled by Pinook-U
Pinook-U is recalling Pinook Mini Massager, distributed nationwide in the US. The recall was initiated on 23 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0176-2014
- FDA event ID
- 66191
- Recalling firm
- Pinook-U, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2013
- FDA classified
- 7 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 May 2013 | Recall initiated by company | |
| 7 Nov 2013 | Classified by FDA | +168 days |
| 13 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failure to submit a premarket submission and gain approval of a medical device.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Where it was distributed
Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
Nationwide ArizonaCaliforniaColoradoFloridaIllinoisMassachusettsMarylandMissouriMontanaNorth CarolinaNorth DakotaNew JerseyNevadaNew YorkPuerto RicoTexasVirginiaWashington
Questions about this recall
Is Pinook Mini Massager recalled?
Yes. Pinook-U recalled Pinook Mini Massager on 23 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0176-2014.
Why was it recalled?
Failure to submit a premarket submission and gain approval of a medical device.
Which lots are affected?
ALL LOTS
Where was it sold?
Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pinook-U
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinook Micro Massager recalled by Pinook-U | Pinook-U | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |