CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Artoura Breast Tissue Expanders Reference Numbers recalled
Mentor Texas is recalling Artoura Breast Tissue Expanders Reference Numbers: Sdc-100UH Sdc-110UH Sdc-120UH, distributed nationwide in the US. The recall was initiated on 18 Feb 2026 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-1687-2026
- FDA event ID
- 98482
- Recalling firm
- Mentor Texas, Irving, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Feb 2026
- FDA classified
- 27 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Breast Implants
Timeline
| 18 Feb 2026 | Recall initiated by company | |
| 27 Mar 2026 | Classified by FDA | +37 days |
| 8 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
Questions about this recall
Why was it recalled?
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Which lots are affected?
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98482This product is part of a recall event; the main page for the event is Artoura Breast Tissue Expanders Reference Numbers recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide | |
| CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide | |
| CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide | |
| CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide | |
| CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide | |
| CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
More recalls from Mentor Texas
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syringe Luer Lok 10cc-200/box Bd recalled by Mentor Texas | Mentor Texas | Device Malfunction | CA, FL, PA |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
Other Breast Implants recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | BBraun Medical Winged INF recalled | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged Infusion, Single PK recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged INF SET recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |