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
Nov 27, 2023	Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear M...	Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall dow...	Class II	Mirion Technologies (Capintec), Inc.
Nov 20, 2023	KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta...	Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instr...	Class II	Keystone Industries
Nov 16, 2023	PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syri...	An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with...	Class II	Becton Dickinson & Company
Nov 14, 2023	CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ...	CARDIOHELP-i System was not properly tested to measure leakage current	Class III	Maquet Medical Systems USA
Nov 13, 2023	Venous probe connection cable (REF 701069333 and 701048804) used with the Car...	Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe con...	Class II	Maquet Medical Systems USA
Nov 8, 2023	Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - A...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and P...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AX...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E -...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light S...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Ca...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numb...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Cata...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 6, 2023	CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxid...	Certain factory settings for the device were incorrectly described in the IFU-related to the warn...	Class II	Maquet Medical Systems USA
Nov 1, 2023	LITe Decompression Snake Arm, REF 48080230	Product arm was manufactured with the incorrect clamp component. As a result, the affected produc...	Class II	Stryker Spine
Nov 1, 2023	Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo...	A software issue where "low" and "terminal" battery alerts did not display on the screen to the u...	Class II	Turncare, Inc
Oct 31, 2023	Acrobat-i Vacuum Positioner System, Model Number XP-5000Z	The Positioner Arm may not tighten or lock during normal use.	Class II	Maquet Cardiovascular, LLC
Oct 31, 2023	ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M	The organization completed a product improvement process to the conjugate found within the certai...	Class II	Zeus Scientific, Inc.
Oct 31, 2023	ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G	The organization completed a product improvement process to the conjugate found within the certai...	Class II	Zeus Scientific, Inc.
Oct 31, 2023	The 4Kscore Test, an in vitro serum or plasma test that combines the results ...	Mathematical modeling of the 4Kscore with and without DRE information was recently performed on o...	Class II	BioReference Health, LLC
Oct 19, 2023	Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit- For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit-For access to the subarachnoid space or the latera...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit -For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit-For access to the subarachnoid space or the latera...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ...	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit - For access to the subarachnoid space or the late...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 12, 2023	Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbe...	It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail ...	Class II	Maquet Medical Systems USA
Oct 11, 2023	BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In...	Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE...	Class II	Becton Dickinson & Company
Oct 11, 2023	BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ...	Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE...	Class II	Becton Dickinson & Company
Oct 11, 2023	BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT...	Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE...	Class II	Becton Dickinson & Company
Oct 10, 2023	CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH...	Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This is...	Class I	Maquet Medical Systems USA
Oct 5, 2023	CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with...	Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to incl...	Class I	Integra LifeSciences Corp.
Sep 22, 2023	DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall...	Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ...	Class II	Musculoskeletal Transplant Foundation, Inc.
Sep 19, 2023	Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri...	Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different...	Class II	Maquet Cardiovascular, LLC
Sep 13, 2023	Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance...	Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epi...	Class II	Maquet Cardiovascular, LLC
Sep 6, 2023	Meera Mobile Operating Table-to support and position the patient immediately ...	Under certain conditions, an issue might prevent the device from performing as intended. A specif...	Class II	Getinge Usa Sales Inc
Sep 1, 2023	Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Male-Female Midsection with the following sizes and model numbers. a. Male...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Numb...	Device reaching End of Service prematurely.	Class II	Angel Medical Systems, 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.