Browse Device Recalls
211 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 211 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 211 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2023 | AcuMatch Hip System, Catalog Number 142-32-27 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Jun 5, 2023 | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| Jun 5, 2023 | Exactech Ergo Impactor Handle, Catalog #321-09-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Number... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 11, 2022 | GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Com... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Ti... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Component... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a.... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylen... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis ... | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip pro... | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech Connexion GXL acetabular polyethylene liners used in the following s... | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... | Class II | Exactech, Inc. |
| May 11, 2021 | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each... | The HAT trial contains a retaining ring that has shown the potential to disengage during use. | Class II | Exactech, Inc. |
| Nov 9, 2020 | Equinoxe Humeral Stem, Primary, Press Fit, 11mm | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primar... | Class II | Exactech, Inc. |
| Oct 6, 2020 | Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium | The product may be mislabeled. | Class II | Exactech, Inc. |
| Oct 6, 2020 | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium | The product may be mislabeled. | Class II | Exactech, Inc. |
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.