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 |
|---|---|---|---|---|
| Aug 9, 2012 | SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE ... | Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... | Class II | Stryker Spine |
| Aug 6, 2012 | Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile;... | During the manufacturing of the affected lot a manufacturing error has led to embrittlement of th... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 31, 2012 | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula... | It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packag... | Class III | Roche Molecular Systems, Inc. |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... | An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... | Class II | Integra Limited |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... | An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... | Class II | Integra Limited |
| Jul 27, 2012 | Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS R... | Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 27, 2012 | Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS ... | Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 19, 2012 | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06... | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control ... | Class III | Abbott Point Of Care Inc. |
| Jul 16, 2012 | DataCara GM is an information management system that provides data management... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The COBAS 8000 data manager modular analyzer series (all versions) is a is a... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extens... | Stryker has become aware that insufficient taper torsional strength may result when a PAR extensi... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 16, 2012 | The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | Data Station AMPLILINK software is an instrument user interface/ data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataCare POC is an information management system that provides data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 5, 2012 | Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... | Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable... | Class II | Stryker Spine |
| Jul 3, 2012 | Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seiza... | Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load ... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 2, 2012 | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman,... | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA... | Class II | Mc-NEIL-PPC, Inc. |
| Jul 2, 2012 | EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceu... | Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in ass... | Class II | Ethicon, Inc. |
| Jun 15, 2012 | STA Satellite Automated Multi-Parameter Analyzer This system is a fully au... | Following a single customer complaint that incorrect INR values were occasionally printed for PT ... | Class II | Diagnostica Stago, Inc. |
| Jun 14, 2012 | The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a ... | Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guide... | Class II | Integra Life Sci. |
| Jun 12, 2012 | QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... | It has come to firm's attention that, in some rare cases, the blood outlet connector on some mode... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 29, 2012 | Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG K... | Certain pediatric arterial cannulas may have limited flexibility due to an increased length of th... | Class II | Maquet Inc. |
| May 23, 2012 | Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(... | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal co... | Class II | Integra Limited |
| May 7, 2012 | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... | Mindray has identified two software anomalies contained in the V Series Monitoring System. There... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| May 7, 2012 | Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products | Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. | Class II | MTI Precision Products LLC. |
| Apr 30, 2012 | Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate C... | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... | Class II | Stryker Howmedica Osteonics Corp. |
| Apr 30, 2012 | ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 ... | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... | Class II | Stryker Howmedica Osteonics Corp. |
| Apr 25, 2012 | The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDA... | The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Ster... | Class II | Stryker Spine |
| Apr 23, 2012 | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spin... | Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from... | Class II | Stryker Spine |
| Apr 23, 2012 | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... | When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK softw... | Class II | Roche Molecular Systems, Inc. |
| Apr 20, 2012 | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse R Grafton is a human bone allograft product containing dem... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse S Multiple sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograf... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 13, 2012 | Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Ver... | As a result of a small number of customer complaints, MAQUET conducted an investigation and ident... | Class II | Maquet Medical Systems, Usa |
| Apr 4, 2012 | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. In... | The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the de... | Class II | Integra LifeSciences Corp |
| Apr 3, 2012 | Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distribut... | The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the po... | Class II | Ethicon, 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.