Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Nov 21, 2017	10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PEN...	The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage...	Class II	Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2017	Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is mar...	The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Li...	Class II	Medica Corporation
Nov 20, 2017	Agility with Integrity R3.2	Potential for positional errors following automatic table movement (ATM).	Class II	Elekta Limited
Nov 20, 2017	Integrity R1.2	Potential for positional errors following automatic table movement (ATM).	Class II	Elekta Limited
Nov 20, 2017	Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ...	The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the ex...	Class II	OMNIlife science Inc.
Nov 20, 2017	Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonito...	While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Win...	Class II	Invivo Corporation
Nov 20, 2017	Tapered Screw-Vent MTX Model TSVTB11	Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a man...	Class II	Zimmer Dental Inc
Nov 20, 2017	Phadia Prime software, article number 12-4101-00, as used in combination with...	We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ...	Class II	Phadia Ab
Nov 20, 2017	RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,...	When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul...	Class II	RAYSEARCH LABORATORIES AB
Nov 17, 2017	EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry tr...	Firm became aware that it distributed 7 units in the U.S. that included a function that had not b...	Class II	Edan Diagnostics
Nov 17, 2017	Proteus 235, Proton Therapy System a medical device designed to produce and d...	There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.	Class II	Ion Beam Applications S.A.
Nov 17, 2017	StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ...	The syringe plunger grippers may fail to automatically close around the syringe plunger press whe...	Class II	CareFusion 303, Inc.
Nov 17, 2017	ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy ...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Sta...	Product not meeting the iodine assay level requirements to support 36 month expiration dating.	Class II	Cypress Medical Products LLC
Nov 17, 2017	TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy tre...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	QuikClot TraumaPad, Part# 460 a topical dressing for local management of blee...	A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of...	Class II	Z-Medica, LLC
Nov 17, 2017	TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy trea...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy tr...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	Specimen Gate Screening Center, Part Number 5002-0500, All software versions ...	Potential errors in patient results generated by the Screening Center product that include both f...	Class II	PerkinElmer Life and Analytical Sciences, Walla...
Nov 17, 2017	Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th...	The syringe plunger grippers may fail to automatically close around the syringe plunger press whe...	Class II	CareFusion 303, Inc.
Nov 17, 2017	IntelliVue X3 Patient Monitor.	The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instea...	Class II	Philips Electronics North America Corporation
Nov 17, 2017	STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 16, 2017	ALM XTEN Surgical Light intended to provide visible illumination for the surg...	Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broke...	Class II	GETINGE US SALES LLC
Nov 16, 2017	Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLin...	Due to a human error at a supplier, an unknown number of devices within one specific production l...	Class II	Brainlab AG
Nov 15, 2017	Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementle...	Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.	Class II	Medacta Usa Inc
Nov 15, 2017	Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated f...	Potential for cracked luer hubs	Class II	Cordis Corporation
Nov 15, 2017	Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect...	The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im...	Class II	Implant Direct Sybron Manufacturing, LLC
Nov 14, 2017	Pressure Injectable Multi- Lumen CVC Kit	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue F...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemo...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591...	The recalled lots have demonstrated unexpected false positive THC results.	Class II	Alere San Diego, Inc.
Nov 14, 2017	Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, ...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and in...	Due to a software error, it was observed that when the user closes the access door, the system wi...	Class II	Carl Zeiss Metrology Inc
Nov 14, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 14, 2017	ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to ...	Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line...	Class II	Arrow International Inc
Nov 13, 2017	HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline co...	A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection...	Class II	Lifeline Systems Company
Nov 13, 2017	VNS Therapy Programmer, Model 3000, v1.0 System	Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo...	Class II	Cyberonics, Inc
Nov 13, 2017	Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps a...	Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi...	Class II	Smiths Medical ASD Inc.
Nov 13, 2017	Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranh...	Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 ...	Class II	Amendia, Inc dba Spinal Elements
Nov 13, 2017	Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps a...	Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi...	Class II	Smiths Medical ASD Inc.
Nov 13, 2017	Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps a...	Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi...	Class II	Smiths Medical ASD Inc.
Nov 10, 2017	Brilliance 64, (Code 728231) Intended to produce images of the head and bo...	Philips has identified that certain fasteners cannot be confirmed to have been torqued according ...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca...	iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc...	Class II	Beckman Coulter 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.