Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 21, 2016
Cellfina Prep Pack, Part No. CP1
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 proc…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ulthera Inc recalled Cellfina Prep Pack, Part No. CP1 - a moderate-severity action.
Cellfina Prep Pack, Part No. CP1 was recalled by Ulthera Inc in December 21, 2016. Reason: It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for U…. Check the official notice for the remedy. Verify recall #Z-0749-2017 with the FDA Devices before acting.
The recall
Ulthera Inc issued this moderate-severity FDA Devices recall-It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for U….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- December 21, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0749-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0749-2017) was formally reported on December 21, 2016, with the manufacturer initiating the action on November 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ulthera Inc is listed as the recalling firm, operating out of Mesa, AZ. Federal records list the affected scope as 6562 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6562 units
Related Recalls
6
3 from same agency
Product description
Cellfina Prep Pack, Part No. CP1
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0749-2017 |
| Date reported | December 21, 2016 |
| Date initiated | November 14, 2016 |
| Recalling firm | Ulthera Inc |
| Firm location | Mesa, AZ |
| Affected scope | 6562 units |
| Distribution | Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0749-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cellfina Prep Pack, Part No. CP1. Recalled by Ulthera Inc. Units affected: 6562 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0749-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0749-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 21, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.