Mentor
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Mentor and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-08FDA-DeviceClass IIMentor BD syringes recalled for expired product distribution
A single lot of 10cc Luer Lok syringes (Lot 8298877) with an expiration date that had passed were distributed to hospitals and medical facilities in California, Florida, and Pennsylvania due to a failure in the distribution system's inventory controls. About 1,401 syringes were affected. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using Mentor Artoura tissue expanders
Mentor Texas has recalled Artoura Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during the expansion procedure and may cause the needle to break.
- 2026-04-08FDA-DeviceClass IIStop using Mentor Artoura Breast Tissue Expanders
The infusion sets included with certain Mentor Artoura Breast Tissue Expanders may have dull or blunt needle tips. This defect can make it difficult to insert the needle during the inflation procedure and may cause the needle to break.
- 2026-04-08FDA-DeviceClass IIStop using Mentor Artoura Breast Tissue Expanders
Mentor Texas, LP is recalling Artoura Breast Tissue Expanders because the infusion sets (the needle and delivery mechanism) may have dull or blunt needle tips. This can make it difficult to insert the needle during the expansion procedure or cause the needle to break.
- 2026-04-08FDA-DeviceClass IIStop using Mentor CPX 4 breast tissue expanders
Mentor Texas breast tissue expanders used in reconstruction surgery may have infusion sets with dull or blunt needle tips. These needles may be difficult to insert during the expansion process and could break inside the device. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using Mentor CPX 4 tissue expanders
Mentor Texas has recalled CPX 4 breast tissue expanders because the infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during treatment or cause it to break. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using Mentor CPX 4 tissue expanders
Mentor Texas has recalled CPX 4 US Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. These dull needles can be hard to insert and may break during use. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IICheck your Mentor CPX 4 tissue expander infusion set
Mentor Texas is recalling certain CPX 4 breast tissue expanders because the infusion sets may have a dull or blunt needle tip. This can make it difficult to insert the needle or cause it to break during use. No injuries have been reported.
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