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.

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DateProductReasonClassFirm
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
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 14, 2020 Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Pati... The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discr... Class II Thomas Scientific
Jun 19, 2020 SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemost... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Inject... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Cata... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Nu... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Por... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 0080... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Ca... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company

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.