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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 9 FDA device recalls.

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DateProductReasonClassFirm
Sep 30, 2021 MENTOR Saline-Filled Breast Implants are constructed from room temperature v... Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch port... Class II Mentor Texas, LP.
Mar 27, 2017 Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Impl... Missing Dome Pack accessory. Class II Mentor Texas, LP.
Aug 9, 2016 Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can b... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Jul 1, 2016 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentatio... The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Class II Mentor Texas, LP.
Dec 11, 2014 MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Bre... The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect.... Class II Mentor Texas, LP.
Jul 2, 2014 EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us... The device labeling is stamped with 330cc and the device is actually 380cc device. Class II Mentor Texas, LP.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.