Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 29, 2015
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Allergan Inc recalled Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expand… - a moderate-severity action.
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expand… was recalled by Allergan Inc in July 29, 2015. Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond…. Check the official notice for the remedy. Verify recall #Z-2103-2015 with the FDA Devices before acting.
The recall
Allergan Inc issued this moderate-severity FDA Devices recall-Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond….
- Moderate
- severity level
- 167 units
- affected scope
- Class II
- classification
- July 29, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2103-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2103-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on June 18, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Allergan Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 167 units total (114 units in US).
The documented reason for this recall is: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. Distribution data in the federal record shows the product reached: US in the state of Canada. 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
167 units total (114 units in US)
Related Recalls
6
3 from same agency
Product description
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Reason for recall
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2103-2015 |
| Date reported | July 29, 2015 |
| Date initiated | June 18, 2015 |
| Recalling firm | Allergan Inc |
| Firm location | Irvine, CA |
| Affected scope | 167 units total (114 units in US) |
| Distribution | US in the state of Canada |
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-2103-2015) 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? ▼
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.. Recalled by Allergan Inc. Units affected: 167 units total (114 units in US).
Why was this product recalled? ▼
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2103-2015.
Where was the recalled product distributed? ▼
Distribution: US in the state of Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2103-2015) 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.
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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 July 29, 2015. 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.