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 |
|---|---|---|---|---|
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 11, 2013 | Sodium Bicarbonate, USP Provided bulk as raw material - label not applicabl... | Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Ol... | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Pro... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| May 30, 2013 | Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long... | Stryker has received reports from customers indicating post-operative fracture of the pin that c... | Class I | Stryker Spine |
| May 21, 2013 | GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedic... | Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. | Class II | Stryker Howmedica Osteonics Corp. |
| May 14, 2013 | MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and ster... | The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 13, 2013 | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm he... | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the ... | Class II | Collagen Matrix Inc |
| May 9, 2013 | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcan... | As a result of the investigation into an adverse trend of complaints for reports of misalignment ... | Class II | Integra LifeSciences Corporation |
| May 1, 2013 | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes... | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw vo... | Class II | Becton Dickinson & Company |
| May 1, 2013 | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. ... | There has been an increase in complaints regarding the needle/safety mechanism disengaging from t... | Class II | Becton Dickinson & Company |
| Apr 26, 2013 | MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The... | MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Apr 26, 2013 | Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biph... | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire wh... | Class II | Cardio Medical Products |
| Apr 9, 2013 | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an in... | Several complaints were recorded regarding one of the three screws driving through the cage of th... | Class II | Ebi, Llc |
| Apr 1, 2013 | cobas¿ 4800 system z480 instrument. Integrates fully automated total nu... | In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.... | Class II | Roche Molecular Systems, Inc. |
| Mar 28, 2013 | Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in sur... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absor... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recomm... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx... | On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were foun... | Class II | Custom Spine, Inc. |
| Mar 28, 2013 | Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regene... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matri... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbab... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant f... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Absorbable Collagen Sponge Provided As Intermediate to Another Company | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of perip... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the m... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix ... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane i... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in su... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable ... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Loc... | Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Dril... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 28, 2013 | HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 25, 2013 | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 8, 2013 | MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen deli... | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. | Class II | Linde Gas North America Llc |
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.