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
Mar 21, 2023	LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Numbe...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM It...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 1...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number:...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: ...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM It...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item N...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Numbe...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 21, 2023	LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 1...	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product...	Class II	Linkbio Corp.
Mar 10, 2023	stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende...	Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produ...	Class II	Howmedica Osteonics Corp.
Mar 10, 2023	VITROS 5600 Integrated System - Refurbished . For use in the in vitro quanti...	MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿...	Class II	Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023	stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intende...	Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produc...	Class II	Howmedica Osteonics Corp.
Mar 10, 2023	VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi...	MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿...	Class II	Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023	VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-qua...	MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿...	Class II	Ortho-Clinical Diagnostics, Inc.
Mar 9, 2023	VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrator...	Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS...	Class II	Ortho-Clinical Diagnostics, Inc.
Mar 6, 2023	VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH...	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Feb 28, 2023	Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) ...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 13, 2023	BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ...	Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ...	Class II	Maquet Medical Systems USA
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c...	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-08...	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c...	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There have been reported failures of the high pressure helium regulator, which may cause a helium...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-080...	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue. Model Number: 0998-00-0800-83.	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, ...	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There have been reported failures of the high pressure helium regulator, which may cause a helium...	Class II	Datascope Corp.
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Sin...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed ...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two U...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designe...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Jan 30, 2023	Fusion Bioline Vascular Graft, Part number M00201503046B0	One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness test...	Class II	Maquet Cardiovascular, LLC
Jan 25, 2023	Easy Read App associated with First Response Pregnancy Test Sticks - Intende...	Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 5...	Class II	Church & Dwight Inc
Dec 22, 2022	Hemopro 2 with Vasoshield, Model VH-4001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Vasoshield Syringe Packs, Model VH-5001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ...	Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent...	Class I	Getinge Usa Sales Inc
Dec 22, 2022	Getinge Flow-c Anesthesia System, Part No. 6887700	Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent...	Class I	Getinge Usa Sales 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.