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.

Clear

Date	Product	Reason	Class	Firm
Jul 14, 2021	Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ...	There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ...	Class II	Maquet Medical Systems USA
Jul 14, 2021	Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrum...	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E...	Class II	Pentax of America Inc
Jul 14, 2021	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-27...	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E...	Class II	Pentax of America Inc
Jul 1, 2021	Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700	The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a w...	Class II	Howmedica Osteonics Corp.
Jun 1, 2021	CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hem...	Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's...	Class II	Integra LifeSciences Corp.
May 27, 2021	3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele...	Telepack may not power on when using the 3AA battery cradle.	Class III	Mindray DS USA, Inc. dba Mindray North America
May 18, 2021	Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, ...	The products experienced a 12-hour excursion from the required refrigerated temperature condition...	Class II	Stryker Spine
May 18, 2021	Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, G...	The products experienced a 12-hour excursion from the required refrigerated temperature condition...	Class II	Stryker Spine
Apr 21, 2021	Pentax Medical Video Duodenoscope - Product Usage: intended to be used with e...	IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duo...	Class II	Pentax of America Inc
Mar 29, 2021	AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surg...	3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery	Class II	Musculoskeletal Transplant Foundation, Inc.
Mar 29, 2021	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intend...	Not manufactured to specification	Class II	Nobel Biocare Procera LLC
Mar 29, 2021	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intend...	Not manufactured to specification	Class II	Nobel Biocare Procera LLC
Mar 29, 2021	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intende...	Not manufactured to specification	Class II	Nobel Biocare Procera LLC
Mar 29, 2021	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intend...	Not manufactured to specification	Class II	Nobel Biocare Procera LLC
Mar 29, 2021	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intend...	Not manufactured to specification	Class II	Nobel Biocare Procera LLC
Mar 25, 2021	cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coron...	Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us...	Class II	Roche Molecular Systems, Inc.
Mar 25, 2021	cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catal...	Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us...	Class II	Roche Molecular Systems, Inc.
Mar 22, 2021	Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor...	There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m...	Class III	Datascope Corp.
Mar 22, 2021	Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor...	There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m...	Class III	Datascope Corp.
Mar 17, 2021	CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Cathe...	Incorrect labeling, Catheter did not have the required holes and markings	Class II	Integra LifeSciences Corp.
Mar 11, 2021	Tritanium X TL Instruments - intervertebral fusion device with bone graft, lu...	Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The...	Class II	Stryker Spine
Mar 5, 2021	Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re...	The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L...	Class II	Howmedica Osteonics Corp.
Feb 22, 2021	Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ...	BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation...	Class II	Mindray DS USA, Inc. dba Mindray North America
Feb 16, 2021	MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE...	Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon ...	Class II	Vectornate USA Inc
Feb 11, 2021	Operating Table System	There is a potential for hydraulic leakage at the inclination function to occur resulting in an u...	Class II	Getinge Group Logistics America, LLC
Feb 10, 2021	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,...	Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Bas...	Class II	Howmedica Osteonics Corp.
Jan 29, 2021	Anesthesia gas-machine - Product Usage: intended for use in administering ane...	Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zer...	Class II	Getinge Group Logistics America, LLC
Jan 4, 2021	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol...	Product distributed with a red tape as part of the sterile packaging which could impact the seal ...	Class II	Ethicon, Inc.
Dec 23, 2020	BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482	The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i...	Class II	Becton Dickinson & Company
Dec 22, 2020	Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement ...	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep...	Class II	Abbott Point Of Care Inc.
Dec 22, 2020	Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of ...	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep...	Class II	Abbott Point Of Care Inc.
Dec 21, 2020	Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber wash...	The potential that the plastic inlet hose connections may deform or break as a result of material...	Class II	Getinge Group Logistics America, LLC
Dec 18, 2020	Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Produ...	Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user inp...	Class II	Topcon Medical Systems, Inc.
Dec 15, 2020	VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentra...	Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product...	Class II	Ortho Clinical Diagnostics Inc
Dec 15, 2020	VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quanti...	Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product...	Class II	Ortho Clinical Diagnostics Inc
Dec 14, 2020	Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use...	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ...	Class II	Integra LifeSciences Corp.
Dec 14, 2020	Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u...	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ...	Class II	Integra LifeSciences Corp.
Dec 11, 2020	VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide car...	VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interfe...	Class II	Ortho Clinical Diagnostics Inc
Dec 9, 2020	BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for adminis...	BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ...	Class II	Becton Dickinson & Company
Dec 9, 2020	BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administ...	BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ...	Class II	Becton Dickinson & Company
Nov 23, 2020	uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871...	When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t...	Class II	Roche Molecular Systems, Inc.
Nov 20, 2020	HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020	HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 19, 2020	The cobas z 480 analyzer including dedicated software for IVD use is a plate-...	Dirty Lens May Cause Invalid or False Positive Results	Class II	Roche Molecular Systems, Inc.
Nov 18, 2020	BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usag...	BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2...	Class II	Becton Dickinson & Company
Nov 11, 2020	Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for...	Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A20...	Class II	Integra LifeSciences Corp.
Oct 23, 2020	PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm	The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus...	Class II	Ethicon, Inc.
Oct 23, 2020	BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ...	Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt...	Class II	Becton Dickinson & Company
Oct 19, 2020	Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral fo...	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t...	Class II	Geistlich Pharma North America, Inc.
Oct 19, 2020	Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for...	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t...	Class II	Geistlich Pharma North America, 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.