Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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Date	Product	Reason	Class	Firm
Nov 21, 2018	da Vinci Xi Surgical System	Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err...	Class II	Intuitive Surgical, Inc.
Nov 21, 2018	Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Progesterone Reagent Kit, List Number 08P3620	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 20, 2018	Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product...	One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking...	Class II	Zimmer Biomet, Inc.
Nov 20, 2018	Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000	The power load floor plates which hold the ambulance cot anchors in place during patient transpor...	Class II	Stryker Medical Division of Stryker Corporation
Nov 20, 2018	Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ...	One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking...	Class II	Zimmer Biomet, Inc.
Nov 19, 2018	St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ...	The device is unable to pair with the mobile app due to the device incorrectly determining the ce...	Class II	Abbott
Nov 19, 2018	Medex High Pressure Stopcock used to control the direction of IV fluid flow. ...	Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m...	Class II	Smiths Medical ASD Inc.
Nov 19, 2018	Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on...	Potentially lead to anchor breakage during insertion,	Class II	Arthrex, Inc.
Nov 19, 2018	SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic...	Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP)...	Class II	Randox Laboratories Ltd.
Nov 19, 2018	Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600...	HVAD Battery Charger units manufactured with wrong inductors.	Class II	Heartware, Inc.
Nov 16, 2018	Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	Presource Kit Total Joint Pack containing a double-wrapped basin component. ...	The double wrapping of this custom kit basin set is not supported by the current sterility assura...	Class II	Cardinal Health Inc.
Nov 16, 2018	Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons...	Lead impedance values reported by the affected VNS generator will be higher compared to those rep...	Class II	LivaNova USA Inc
Nov 16, 2018	VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly	This recall is being initiated due to reports that that the therapy programming tablet with softw...	Class II	LivaNova USA Inc
Nov 16, 2018	Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P ...	Invacare has identified via customer complaints, the potential for the mounting bolt connecting t...	Class II	Invacare Corporation
Nov 16, 2018	Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-...	The product was packaged with the Instructions for Use for a different product (Ascension First C...	Class III	Ascension Orthopedics, Inc
Nov 15, 2018	HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE	Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19	Class II	Howmedica Osteonics Corp.
Nov 15, 2018	Various GE Magnetic Resonance System on-site software version Product Usag...	Possible incorrect software version loaded.	Class II	GE Healthcare, LLC
Nov 15, 2018	V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180	During in-house testing it was determined that their is a possibility that during a sample run, ...	Class II	Vital Scientific N.V.
Nov 15, 2018	Revanesse Versa, PN40081	Labeling error. The product is labeled with an 18 month expiration date, however the product is a...	Class II	Prollenium Medical Technologies Inc.
Nov 15, 2018	Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Mat...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Nov 15, 2018	Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Mate...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Nov 15, 2018	Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1...	There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plott...	Class II	Philips Electronics North America Corporation
Nov 15, 2018	Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, ...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Nov 15, 2018	HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE	Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19	Class II	Howmedica Osteonics Corp.
Nov 14, 2018	Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are ...	There have been reports of shortened (T1-T2) results, where some instances of result recovery out...	Class II	Diagnostica Stago, Inc.
Nov 14, 2018	Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with ...	The lidstock states the incorrect priming volume and flow rates.	Class II	Arrow International Inc
Nov 14, 2018	Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT...	Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.	Class II	Zimmer Biomet, Inc.
Nov 14, 2018	NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Nu...	The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. T...	Class II	In2bones USA, LLC
Nov 14, 2018	Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits ar...	There have been reports of shortened (T1-T2) results, where some instances of result recovery out...	Class II	Diagnostica Stago, Inc.
Nov 14, 2018	ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Eur...	A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or ...	Class II	Swissray Medical AG
Nov 13, 2018	Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ...	Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa...	Class II	Stryker Neurovascular
Nov 13, 2018	Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVisi...	During a post approval study the firm found there was an increased risk of corneal haze following...	Class I	RVO 2.0, INC
Nov 13, 2018	EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surg...	There is a potential the joint in the suspension of the device is insufficiently assembled.	Class II	Stryker Communications
Nov 13, 2018	VITEK¿ 2 Systems Software Version 9.01 Update Kit.	The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification...	Class II	bioMerieux, Inc.
Nov 12, 2018	Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with...	Insufficient seal on the sterile barrier of the device, compromising the sterility of the device	Class II	Bracco Injeneering S.A.
Nov 12, 2018	RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,...	Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, Ray...	Class II	RAYSEARCH LABORATORIES AB
Nov 9, 2018	AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25...	Beckman Coulter has identified a case where a customer using the microltiterplate kit option with...	Class II	Beckman Coulter Inc.
Nov 9, 2018	Perfusion Pack, Rx only, Sterile EO	4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated fo...	Class II	LivaNova USA
Nov 9, 2018	TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter ...	A limited number of lenses may be mislabeled with the incorrect diopter power.	Class II	Tekia, Inc.
Nov 9, 2018	Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, ...	Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and ...	Class II	GE Healthcare, LLC
Nov 8, 2018	Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Na...	Unintentional U-Arm movement	Class II	Konica Minolta Healthcare, Americas, Inc.
Nov 8, 2018	SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I...	There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow...	Class II	ICU Medical Inc
Nov 7, 2018	Philips Volcano FFR software used in the following systems connected to the M...	Interoperability issue that affects certain systems that use the recalled software when it is con...	Class II	Volcano Corporation
Nov 7, 2018	Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stati...	kV/mA lockin not functioning as specified which may result in the patient receiving an increased ...	Class II	Philips Medical Systems Gmbh, DMC
Nov 7, 2018	Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-...	Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm ...	Class II	Hager & Meisinger Gmbh
Nov 6, 2018	IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000,...	Table may drift in the roll position while in use	Class II	Deerfield Imaging, Inc.
Nov 6, 2018	IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product ...	Table may drift in the roll position while in use	Class II	Deerfield Imaging, 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.