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 17, 2020	PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Cat...	Iincorrectly packaged without the required lidocaine as labeled	Class II	Becton Dickinson & Company
Mar 4, 2020	STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno...	A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago inst...	Class II	Diagnostica Stago, Inc.
Mar 3, 2020	Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 -...	It is possible that the collimators have screw hole locations that were insufficiently tapped. T...	Class II	Capintec Inc
Feb 26, 2020	BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 20, 2020	Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039	A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 10, 2020	Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and...	Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situ...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 7, 2020	NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U...	Nonconforming product which was dispositioned for rejection was mistakenly released for commercia...	Class III	Integra LifeSciences Corp.
Jan 16, 2020	Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ...	Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th...	Class III	Maquet Cardiovascular Us Sales, Llc
Jan 16, 2020	Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ...	Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th...	Class III	Maquet Cardiovascular Us Sales, Llc
Jan 15, 2020	i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 -...	The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status...	Class II	Abbott Point Of Care Inc.
Jan 15, 2020	i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Pr...	The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status...	Class II	Abbott Point Of Care Inc.
Jan 14, 2020	i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Pro...	Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient ...	Class II	Abbott Point Of Care Inc.
Jan 13, 2020	DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - ...	The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 3, 2020	Pentax Video Colonoscope Model: EC34-i10L	Distributed in the USA without an approved 510K	Class II	Pentax of America Inc
Jan 3, 2020	Pentax Video Colonoscope Model: EC38-i10L	Distributed in the USA without an approved 510K	Class II	Pentax of America Inc
Jan 3, 2020	Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The de...	Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced t...	Class II	Ethicon, Inc.
Dec 16, 2019	VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/35...	Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Product...	Class II	Ortho Clinical Diagnostics Inc
Dec 9, 2019	BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Cont...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 9, 2019	ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 3, 2019	Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. ...	A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 20, 2019	Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ...	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer...	Class II	Datascope Corporation
Nov 20, 2019	Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i...	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer...	Class II	Datascope Corporation
Nov 20, 2019	Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an...	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer...	Class II	Datascope Corporation
Nov 18, 2019	STA UNICALIBRATOR (ref. 00675)	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX...	Class II	Diagnostica Stago, Inc.
Nov 18, 2019	STA SYSTEM CONROL N + P (ref. 00678)	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX...	Class II	Diagnostica Stago, Inc.
Nov 13, 2019	Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane...	Sterile barrier system may be compromised	Class II	GETINGE US SALES LLC
Nov 7, 2019	Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless...	May have a missing locking wire causing delay in surgery while retrieving a back-up device or imp...	Class II	Howmedica Osteonics Corp.
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Prod...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 5, 2019	GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 -...	The products may have been packaged with an incorrect Instructions for Use.	Class II	Collagen Matrix Inc
Nov 4, 2019	Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ...	The indicator may show available charge when the battery is close to depletion. As a result, the ...	Class II	Becton Dickinson & Company
Nov 4, 2019	Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product...	Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa...	Class II	Integra Lifesciences Sales Llc
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.
Oct 21, 2019	C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr...	Class II	Integra LifeSciences Corp.

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.