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 |
|---|---|---|---|---|
| Feb 3, 2026 | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata... | Impactor handle may be missing cross-pin | Class II | Exactech, Inc. |
| Feb 3, 2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/... | Impactor handle may be missing cross-pin | Class II | Exactech, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Dec 31, 2024 | Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 31, 2024 | Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 31, 2024 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-2... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26M... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mate... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, I... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 4... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, It... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b)... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mat... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-00... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Novation Hip System, Catalog Numbers: 134-36-45 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | 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.