Browse Device Recalls
2,036 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,036 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 2,036 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 31, 2024 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... | Class II | Maquet Cardiovascular, LLC |
| May 31, 2024 | The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... | Class II | Maquet Cardiovascular, LLC |
| May 29, 2024 | CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... | Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... | Class II | Integra LifeSciences Corp. |
| May 29, 2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... | Class II | Getinge Usa Sales Inc |
| May 29, 2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... | Class II | Getinge Usa Sales Inc |
| May 29, 2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... | Class II | Getinge Usa Sales Inc |
| May 23, 2024 | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... | Class II | Howmedica Osteonics Corp. |
| May 23, 2024 | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 621... | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... | Class II | Howmedica Osteonics Corp. |
| May 17, 2024 | The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... | Class II | Maquet Cardiovascular, LLC |
| May 17, 2024 | The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... | Class II | Maquet Cardiovascular, LLC |
| May 10, 2024 | MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 7, 2024 | CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... | Class II | Integra LifeSciences Corp. |
| May 1, 2024 | Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... | Class I | Getinge Usa Sales Inc |
| Apr 23, 2024 | SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. | Some applicator tips from these lots had open seals. | Class II | Ethicon, Inc. |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended t... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform ... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Up... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 17, 2024 | Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... | Class II | Integra LifeSciences Corp. |
| 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 | 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 | 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. |
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.