Browse Device Recalls
2,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,057 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 2,057 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. | The firm identified that the measured patient leakage current in some devices significantly excee... | Class II | Maquet Medical Systems USA |
| Mar 28, 2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configur... | Class II | Horiba Instruments Incorporated |
| Mar 22, 2024 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 22, 2024 | 20" Lead Wires, Replacement Part Number: 1067724-2 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 22, 2024 | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte c... | Product demonstrates low viscosity. | Class II | Parker Laboratories, Inc. |
| Mar 22, 2024 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 22, 2024 | 48" Lead Wires, Replacement Part Number: 1067724-4 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 8, 2024 | STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: ... | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions du... | Class II | Ethicon, Inc. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 7 9 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 3 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Jan 22, 2024 | Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 i... | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. | Class II | Parker Laboratories, Inc. |
| Jan 19, 2024 | Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 16, 2024 | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7... | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... | Class II | Maquet Medical Systems USA |
| Jan 16, 2024 | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078.... | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 5, 2024 | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Min... | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging e... | Class II | IMPULSE DYNAMICS (USA) INC |
| Dec 28, 2023 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... | Class II | Maquet Medical Systems USA |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
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.