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Mentor Texas LP FDA Recalls
9 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, PistonClass IIApr 28, 2026A single lot of expired syringes were distributed due to a d |
| Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Class IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650Class IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH SmClass IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPClass IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1Class IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height TisClass IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150Class IIFeb 18, 2026Infusion sets may contain dull/blunt needle tip, which may b |
| MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydClass IISep 30, 2021Due to a manufacturing issue, Implant may have a potentially |