Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Jul 25, 2019	Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Prod...	Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range wa...	Class III	Randox Laboratories Ltd.
Jul 25, 2019	syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog...	SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ...	Class II	Siemens Medical Solutions USA, Inc
Jul 25, 2019	Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is desi...	The seal integrity of the sterile bag containing the kits may be compromised.	Class II	Stryker GmbH
Jul 25, 2019	Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is desi...	The seal integrity of the sterile bag containing the kits may be compromised.	Class II	Stryker GmbH
Jul 25, 2019	Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed ...	The seal integrity of the sterile bag containing the kits may be compromised.	Class II	Stryker GmbH
Jul 24, 2019	RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the im...	The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn po...	Class II	Exactech, Inc.
Jul 24, 2019	McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Hemospray Endoscopic Hemostat	Potential for Hemospray device to be unable to spray powder due to misassembly of devices.	Class II	Wilson-Cook Medical Inc.
Jul 24, 2019	The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late...	incorrect device size being listed on the impacted device packaging	Class II	LeMaitre Vascular, Inc.
Jul 24, 2019	Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, St...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 23, 2019	'n'-Hole Post which is a component of the Revolution External Fixation System...	The threads on posts stripping out when tensioned during application process.	Class II	New Standard Device Inc
Jul 23, 2019	Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Mod...	Inaccurately Low Sample Results	Class II	Roche Diagnostics Operations, Inc.
Jul 23, 2019	OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ...	Acetabular liners failed the oxidation testing performed prior to release. They may experience a ...	Class II	OMNIlife science Inc.
Jul 23, 2019	OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ...	Acetabular liners failed the oxidation testing performed prior to release. They may experience a ...	Class II	OMNIlife science Inc.
Jul 23, 2019	AggreGuide A-100 Instrument	The firm identified a software design issue where the improper shut down of the instrument result...	Class II	Aggredyne, Inc.
Jul 23, 2019	Mammomat Revelation with software version VC10 and Biopsy Option Intended ...	An error can occur when performing a biopsy using the InSpect function. The acquisition workstati...	Class II	Siemens Medical Solutions USA, Inc
Jul 23, 2019	ROTEM ex-tem; US Part No: 503-05-US	Prolonged clotting times	Class II	Instrumentation Laboratory Co.
Jul 23, 2019	ROTEM ex-tem Rest of the world part No: 503-05 (ROW)	Prolonged clotting times	Class II	Instrumentation Laboratory Co.
Jul 23, 2019	ROTEM ex-tem Canada Part No: 503-05-CA	Prolonged clotting times	Class II	Instrumentation Laboratory Co.
Jul 23, 2019	Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Modu...	Inaccurately Low Sample Results	Class II	Roche Diagnostics Operations, Inc.
Jul 23, 2019	OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ...	Acetabular liners failed the oxidation testing performed prior to release. They may experience a ...	Class II	OMNIlife science Inc.
Jul 22, 2019	DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane...	Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the c...	Class II	DeRoyal Industries Inc
Jul 22, 2019	Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof...	Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ...	Class II	Zeus Scientific, Inc.
Jul 22, 2019	Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.	Reversed expiration and manufacturing date on the label	Class II	GETINGE US SALES LLC
Jul 22, 2019	Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in s...	Homocysteine Assay May Cause Elevated Results in the Folate Assay	Class II	Siemens Healthcare Diagnostics, Inc
Jul 22, 2019	Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red...	Homocysteine Assay May Cause Elevated Results in the Folate Assay	Class II	Siemens Healthcare Diagnostics, Inc
Jul 22, 2019	Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red b...	Homocysteine Assay May Cause Elevated Results in the Folate Assay	Class II	Siemens Healthcare Diagnostics, Inc
Jul 19, 2019	MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to...	Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause...	Class III	Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jul 19, 2019	ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagn...	Residual crystallization of the microplate and recurrent negative controls out of range.	Class II	Aniara Diagnostica LLC
Jul 19, 2019	Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3....	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-91...	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Fujifilm FDR Go Plus mobile X-ray system	The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)	Class II	Fujifilm Medical Systems U.S.A., Inc.
Jul 19, 2019	AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ...	Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..	Class II	Boston Scientific Corporation
Jul 19, 2019	Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, gr...	Tips have an inadequate product insulation coating, which could result in the tips not coagulatin...	Class II	Integra LifeSciences Corp.
Jul 19, 2019	Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910...	Complaints have been received regarding difficulty in removing the driver from the screw. High d...	Class II	Stryker Corporation
Jul 19, 2019	Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023...	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Produc...	The thickness of the connector to the trunk cable on affected limb lead sets may be greater than ...	Class II	Philips North America, LLC

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.