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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Date	Product	Reason	Class	Firm
Sep 1, 2023	Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Aug 25, 2023	Detector H. Pylori, Catalog Number IHP-30	Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ...	Class II	Immunostics, Inc.
Aug 10, 2023	Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo...	A software update corrected an issue where "low" and "terminal" battery alerts did not display on...	Class II	Turncare, Inc
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ...	Class II	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were identifying autofill failure conditions on the devices causing pump stops.	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ...	Class II	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were identifying autofill failure conditions on the devices causing pump stops.	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting that the device was not charging as expected. It was discovered that users w...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting that the device was not charging as expected. It was discovered that users w...	Class I	Datascope Corp.
Jul 21, 2023	Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ...	A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ...	Class II	Keystone Industries
Jun 28, 2023	ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 23, 2023	SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 6, 2023	NanoZoomer S360MD Slide scanner system-automated system for creating, viewing...	If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the who...	Class II	Hamamatsu Corporation
Jun 5, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru...	Class I	Datascope Corp.
May 18, 2023	HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypas...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary by...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass M...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Mo...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary by...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA

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.