Cellfina Prep Pack, Part No. CP1 recallZ-0749-2017 · Ulthera Inc · initiated Nov 14, 2016
Class II Terminated All recalls posted in December 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ulthera Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
FDA root cause category: Other
What the company is doing
Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at [email protected].
Recall details
- Recall number
- Z-0749-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 14, 2016
- Posted by the FDA
- Dec 13, 2016
- Recalling firm
- Ulthera Inc
- Quantity
- 6562 units
- Product code
- OUP
- FDA submissions
- K161885
- Distribution
- Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
Product description
Cellfina Prep Pack, Part No. CP1
Code information (models, lots, serial numbers)
all
Other devices under the same FDA submission
3 devices cleared under K161885 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cellfina System Disposable Procedure Kit Rev OUlthera, Inc. · Powered Surgical Instrument For Improvement In The Appearance Of Cellulite4 reports
- Cellfina System Disposable Tray CK1 Rev JUlthera, Inc. · Powered Surgical Instrument For Improvement In The Appearance Of Cellulite1 report
- Cellfina System Disposable Tray CK1 Rev KUlthera, Inc. · Powered Surgical Instrument For Improvement In The Appearance Of Cellulite1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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