Browse Device Recalls
2,093 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,093 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 2,093 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 7, 2019 | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | The luer could break and cause the device to leak or break off and get stuck in the fistula needl... | Class II | Becton Dickinson & Company |
| Mar 7, 2019 | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle... | Class II | Becton Dickinson & Company |
| Mar 6, 2019 | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program t... | When a patient is selected in the patient data and another patient is selected prior to the displ... | Class II | Topcon Medical Systems, Inc. |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 1, 2019 | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use i... | Leak from the septum assembly or the canister may burst under high pressure which could result in... | Class II | Becton Dickinson & Company |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - ... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - ... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - P... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Feb 28, 2019 | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... | Class I | Becton Dickinson & Company |
| Feb 8, 2019 | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio... | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled inc... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Jan 24, 2019 | AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mis... | Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump... | Class II | Maquet Cardiovascular, LLC |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Num... | The affected flat screen monitor holders might not be compliant with grounding requirements. As a... | Class II | GETINGE US SALES LLC |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuratio... | The affected flat screen monitor holders might not be compliant with grounding requirements. As a... | Class II | GETINGE US SALES LLC |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Par... | The affected flat screen monitor holders might not be compliant with grounding requirements. As a... | Class II | GETINGE US SALES LLC |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD... | The affected flat screen monitor holders might not be compliant with grounding requirements. As a... | Class II | GETINGE US SALES LLC |
| Dec 20, 2018 | CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The C... | Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customer... | Class I | TERRIFIC CARE LLC |
| Dec 19, 2018 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340... | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Class II | Reckitt Benckiser LLC |
| Dec 19, 2018 | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-987... | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Class II | Reckitt Benckiser LLC |
| Dec 18, 2018 | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr... | The sutures inside the packaging are not the same size or type as indicated on the label. | Class II | Ethicon, Inc. |
| Nov 29, 2018 | Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration... | A stability issue in the calibrators may cause calibration failures or atypical Quality Control r... | Class II | Ortho Clinical Diagnostics Inc |
| Nov 28, 2018 | Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Int... | The surgical technique is being updated to caution against misuse due to reports of cage fracture... | Class II | Howmedica Osteonics Corp. |
| Nov 26, 2018 | Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blu... | Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface... | Class II | Howmedica Osteonics Corp. |
| Nov 15, 2018 | HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE | Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 | Class II | Howmedica Osteonics Corp. |
| Nov 15, 2018 | HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE | Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19 | Class II | Howmedica Osteonics Corp. |
| Nov 14, 2018 | Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are ... | There have been reports of shortened (T1-T2) results, where some instances of result recovery out... | Class II | Diagnostica Stago, Inc. |
| Nov 14, 2018 | Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits ar... | There have been reports of shortened (T1-T2) results, where some instances of result recovery out... | Class II | Diagnostica Stago, Inc. |
| Nov 5, 2018 | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | There is a potential for the spring arm failure as a result of a broken tension rod (a component ... | Class II | Capintec Inc |
| Nov 5, 2018 | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 | There is a potential for the spring arm failure as a result of a broken tension rod (a component ... | Class II | Capintec Inc |
| Oct 30, 2018 | Porcine Anorganic Bone Mineral 4.0cc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an... | Class III | Collagen Matrix Inc |
| Oct 25, 2018 | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000... | There is a potential for blood leakage at the blood inlet connector when using the reducing screw... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Oct 25, 2018 | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10... | There is a potential for blood leakage at the blood inlet connector when using the reducing screw... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Sep 26, 2018 | PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: ... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Sep 26, 2018 | PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usag... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Sep 20, 2018 | AS-OBGYN Information System version 7.824.x | Any change made to current ultrasound machine software or hardware upgrades, adding or modifying ... | Class II | AS Software, Inc. |
| Sep 20, 2018 | Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 | There is a potential for interruption and/or inability to start therapy to the patient prior to o... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
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.