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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DateProductReasonClassFirm
Dec 22, 2022 Getinge Flow-e Anesthesia System, Part No. 6887900 Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Dec 21, 2022 cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test ... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Dec 19, 2022 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... Class I Datascope Corp.
Dec 19, 2022 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... Class I Datascope Corp.
Dec 2, 2022 Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6... Integra LifeSciences identified that one lot was released with out-of-specification endotoxin res... Class II Integra LifeSciences Corp.
Nov 18, 2022 The 4Kscore Test is an in vitro serum or plasma test that combines the result... SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results Class II BioReference Health, LLC
Nov 16, 2022 PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product C... knot tensile strengths were observed to be significantly below the minimum knot tensile, will res... Class II Ethicon, Inc.
Nov 8, 2022 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Impla... No expiration dates printed on the packaging Class II ENDO Pharmaceuticals Solutions, Inc.
Nov 7, 2022 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... The power backup battery, under certain conditions, may exhibit reduced battery run-time while in... Class II Getinge Usa Sales Inc
Nov 7, 2022 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Oct 21, 2022 Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog N... Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had o... Class II Howmedica Osteonics Corp.
Oct 14, 2022 Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and ... The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a pa... Class II Getinge Usa Sales Inc
Oct 13, 2022 VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides F... Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathem... Class II Ortho-Clinical Diagnostics, Inc.
Sep 20, 2022 STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ... Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may re... Class II Ethicon, Inc.
Sep 15, 2022 BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog... The affected product contains isobutylene which has recently demonstrated potential interference ... Class II Becton Dickinson & Company
Sep 8, 2022 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymeras... Reported false positive and invalid results on the affected devices due to anomalous baselines. T... Class II Roche Molecular Systems, Inc.
Aug 24, 2022 Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis co... A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ... Class II Howmedica Osteonics Corp.
Aug 8, 2022 PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, ... Product may contain the incorrect material which could impact treatment. Class II Ethicon, Inc.
Aug 5, 2022 Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II Datascope Corporation
Aug 5, 2022 Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II Datascope Corporation
Aug 5, 2022 MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II Datascope Corporation
Aug 5, 2022 LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. in... The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal ... Class II Datascope Corporation
Aug 3, 2022 Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product wa... The packaging may not be sealed, which could compromise sterility. Class II Collagen Matrix Inc
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 21, 2022 Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... Device does not meet regulatory requirements of stability while stationary, which requires mechan... Class II Getinge Usa Sales Inc
Jul 20, 2022 Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... Ventilators may generate a combination of alarms which may result in loss of communication, techn... Class I Getinge Usa Sales Inc
Jul 18, 2022 BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... Incorrect expiration date listed on the product labels. The expiration date listed on the product... Class II Becton Dickinson & Company
Jun 23, 2022 INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... Class II Mallinckrodt, LLC.
Jun 22, 2022 CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... Class I Integra LifeSciences Corp.
Jun 21, 2022 etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. Device was marketed without FDA 510(k) clearance or a PMA. Class II Touch US Llc
May 9, 2022 BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches... May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836... May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 9, 2022 BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) May have the potential for leakage at the housing component of the stopcock, may result in delay ... Class II Becton Dickinson & Company
May 6, 2022 VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600... Paint particles may detach and fall in the operating field. In the worst case scenario, infection... Class II Getinge Usa Sales Inc
May 2, 2022 Flow-e Anesthesia System : Intended for use in administering anesthesia while... Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... Class I Getinge Usa Sales Inc
May 2, 2022 Flow-c Anesthesia System : intended for use in administering anesthesia whil... Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... 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.