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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.