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 |
|---|---|---|---|---|
| Dec 22, 2020 | Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement ... | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep... | Class II | Abbott Point Of Care Inc. |
| Dec 22, 2020 | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of ... | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep... | Class II | Abbott Point Of Care Inc. |
| Dec 21, 2020 | Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber wash... | The potential that the plastic inlet hose connections may deform or break as a result of material... | Class II | Getinge Group Logistics America, LLC |
| Dec 18, 2020 | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Produ... | Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user inp... | Class II | Topcon Medical Systems, Inc. |
| Dec 15, 2020 | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentra... | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product... | Class II | Ortho Clinical Diagnostics Inc |
| Dec 15, 2020 | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quanti... | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product... | Class II | Ortho Clinical Diagnostics Inc |
| Dec 14, 2020 | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 14, 2020 | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 11, 2020 | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide car... | VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interfe... | Class II | Ortho Clinical Diagnostics Inc |
| Dec 9, 2020 | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for adminis... | BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... | Class II | Becton Dickinson & Company |
| Dec 9, 2020 | BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administ... | BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... | Class II | Becton Dickinson & Company |
| Nov 23, 2020 | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871... | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t... | Class II | Roche Molecular Systems, Inc. |
| Nov 20, 2020 | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/... | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Nov 20, 2020 | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ... | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Nov 19, 2020 | The cobas z 480 analyzer including dedicated software for IVD use is a plate-... | Dirty Lens May Cause Invalid or False Positive Results | Class II | Roche Molecular Systems, Inc. |
| Nov 18, 2020 | BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usag... | BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2... | Class II | Becton Dickinson & Company |
| Nov 11, 2020 | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for... | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A20... | Class II | Integra LifeSciences Corp. |
| Oct 23, 2020 | PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm | The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus... | Class II | Ethicon, Inc. |
| Oct 23, 2020 | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ... | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt... | Class II | Becton Dickinson & Company |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral fo... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for fi... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 16, 2020 | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use... | Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verif... | Class III | Ortho Clinical Diagnostics Inc |
| Oct 8, 2020 | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) quali... | Product does not meet internal testing criterion; use of the product may result in a potential fa... | Class II | Enterix, Inc. |
| Sep 30, 2020 | Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to mo... | The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Sep 30, 2020 | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: I... | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... | Class II | Ortho Clinical Diagnostics Inc |
| Sep 30, 2020 | VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage... | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... | Class II | Ortho Clinical Diagnostics Inc |
| Sep 24, 2020 | Yuno II Mobile Operating Table - Product Usage: support and position the pati... | Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts expos... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Sep 24, 2020 | Yuno Mobile Operating Table - Product Usage: Intended for support and positio... | Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts expos... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Sep 22, 2020 | 9310HD Digital Video Capture Module with software version 3.4.0 or higher con... | There is an intermittent software issue that could affect the systems, in which an exam video for... | Class II | Pentax of America Inc |
| Sep 22, 2020 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | There is an intermittent software issue that could affect the systems, in which an exam video for... | Class II | Pentax of America Inc |
| Sep 17, 2020 | Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage... | A potentially shorter than specified nebulizer connector may result in difficulty in installing t... | Class II | Getinge Group Logistics America, LLC |
| Sep 14, 2020 | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the p... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the pe... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref... | Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay ... | Class II | Becton Dickinson & Company |
| Sep 9, 2020 | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ... | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. T... | Class II | Ethicon, Inc. |
| Aug 13, 2020 | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 1030... | The firm registered the product as a Class I device, but has since been informed by FDA that the ... | Class II | Pharmaceutical Innovations, Inc. |
| Aug 7, 2020 | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: In... | Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This d... | Class III | Maquet Cardiovascular Us Sales, Llc |
| Aug 4, 2020 | Integra Padgett Electric Dermatome Set - Product Usage: are intended for use ... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
| Aug 4, 2020 | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 a... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
| Aug 4, 2020 | Integra Padgett Dermatome Set - Product Usage: are intended for use in the cu... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
| Jul 28, 2020 | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack | Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are ... | Class II | Becton Dickinson & Company |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan)... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
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.