CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP
Mentor Texas is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 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-1681-2026
- 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
- Surgical Instruments
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
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
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?
00081317006671 00081317006794 00081317006800
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 | 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 | Artoura Breast Tissue Expanders Reference Numbers recalled | 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 | 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 | 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 |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |