Medical device recalls in 2018What FDA recall data shows

Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026

Key findings

The FDA posted 783 medical device recall records in 2018, from 227 recall events by 148 companies — 22% fewer than the same period of 2017 (1,009).
132 records (17%) are Class I, the most serious category (same period of 2017: 46).
The product line named in the most recall records was VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM (Orthofix Srl), with 20.
Zimmer Biomet, Inc. had the most recall events (12, covering 164 records).
The most common FDA root-cause category was “Under Investigation by firm” (26% of records).

Recall records by month

31Jan 68Feb 82Mar 43Apr 161May 54Jun 48Jul 43Aug 186Sep 32Oct 29Nov 6Dec

Red = Class I. Click a month for every recall posted that month.

Most-recalled product lines

Product lines whose models are named by device identifier in recall records posted in 2018.

Product	Company	Recall records	Class I
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM	Orthofix Srl	20	—
Endo GIA	Covidien LP	8	—
OptiView Amplification Kit	Ventana Medical Systems, Inc.	3	3
iVIEW DAB Detection Kit	Ventana Medical Systems, Inc.	3	3
Tapered Screw-Vent	ZimVie US Corp LLC	2	—
Seeker	Bard Peripheral Vascular, Inc.	2	—
QUADROX-i	Maquet Cardiopulmonary AG	2	2
Cypass	Alcon Laboratories, Inc.	2	2
Capio SLIM	Boston Scientific Corporation	2	—
Capio	Boston Scientific Corporation	2	—
BD Vacutainer SST	Becton, Dickinson And Company	2	—
ATTUNE	Depuy (Ireland)	2	—

Companies with the most recall events

Company	Events	Records	Class I
Zimmer Biomet, Inc.	12	164	—
Philips Electronics North America Corporation	6	45	—
Siemens Medical Solutions USA, Inc	5	11	—
GE Healthcare, LLC	5	10	4
Smith & Nephew, Inc.	5	8	—
Vyaire Medical	4	42	42
Arrow International Inc	4	23	—
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	4	19	8
Boston Scientific Corporation	4	16	—
DePuy Orthopaedics, Inc.	4	6	—
Baxter Healthcare Corporation	3	11	—
Roche Diagnostics Corporation	3	6	1

Companies that assemble kits or reprocess devices often appear high: when a component is recalled, every kit that contains it gets its own record.

Most-recalled device types

Device type (FDA product code)	Records	Class I
Rod, Fixation, Intramedullary And Accessories HSB	143	—
Staple, Implantable GDW	55	—
Cardiopulmonary resuscitation aid kit OEV	35	35
Solid state x-ray imager (flat panel/digital imager) MQB	28	—
Plate, Fixation, Bone HRS	25	—
System, x-ray, angiographic IZI	19	—
Immunohistochemistry Reagents And Kits NJT	18	18
Catheter,intravascular,therapeutic,short-term less than 30 days FOZ	15	—
Interventional Fluoroscopic X-Ray System OWB	13	—
System, nuclear magnetic resonance imaging LNH	13	—
Pin, Fixation, Smooth HTY	13	—
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI	11	—

Why devices were recalled

FDA root-cause category	Records	Share
Under Investigation by firm	206	26%
Device Design	181	23%
Process control	126	16%
Nonconforming Material/Component	44	6%
Component design/selection	37	5%
Error in labeling	35	4%
Software design	20	3%
Employee error	20	3%
Other	17	2%
Process design	14	2%
Labeling mix-ups	13	2%
Labeling design	11	1%

“Under Investigation by firm” means the company had not yet reported a root cause when the record was posted.

All Class I recalls in 2018 (132)

StealthStation Cranial and Synergy Cranial Depth Gauge:Class I
Z-0552-2019 · Medtronic Navigation, Inc. · posted Dec 29, 2018 · Terminated
Puritan Bennett 980 (PB980) ventilator series: ↗Class I
Z-0497-2019 · Covidien LLC · posted Dec 18, 2018 · Terminated
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers:Class I
Z-0463-2019 · GE Healthcare, LLC · posted Nov 30, 2018 · Terminated
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part…Class I
Z-0436-2019 · Maquet Cardiovascular Us Sales, Llc · posted Nov 28, 2018 · Terminated
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part…Class I
Z-0437-2019 · Maquet Cardiovascular Us Sales, Llc · posted Nov 28, 2018 · Terminated
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2Class I
Z-0470-2019 · Synaptive Medical Inc · posted Nov 26, 2018 · Terminated
1) Cytomics FC 500 With CXP Software BECKMAN COULTER ↗Class I
Z-0471-2019 · Beckman Coulter Inc. · posted Nov 20, 2018 · Terminated
COULTER EPICS XL Flow Cytometer ↗Class I
Z-0472-2019 · Beckman Coulter Inc. · posted Nov 20, 2018 · Terminated
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System ↗Class I
Z-0369-2019 · GE Healthcare, LLC · posted Nov 14, 2018 · Terminated
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System ↗Class I
Z-0370-2019 · GE Healthcare, LLC · posted Nov 14, 2018 · Terminated
GE Healthcare Millennium MC ↗Class I
Z-0371-2019 · GE Healthcare, LLC · posted Nov 14, 2018 · Terminated
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and…Class I
Z-0391-2019 · Oscor, Inc. · posted Nov 8, 2018 · Terminated
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 ↗Class I
Z-0269-2019 · OriGen Biomedical, Inc. · posted Nov 7, 2018 · Terminated
CoaguChek XS System Prothrombin time test:Class I
Z-0360-2019 · Roche Diagnostics Corporation · posted Nov 2, 2018 · Terminated
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53Class I
Z-0099-2019 · Maquet Datascope Corp - Cardiac Assist Division · posted Oct 27, 2018 · Open, Classified
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83Class I
Z-0100-2019 · Maquet Datascope Corp - Cardiac Assist Division · posted Oct 27, 2018 · Open, Classified
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.Class I
Z-0185-2019 · Alcon Research, LTD. · posted Oct 23, 2018 · Terminated
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001.… ↗Class I
Z-0186-2019 · Alcon Research, LTD. · posted Oct 23, 2018 · Terminated
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.Class I
Z-0187-2019 · Alcon Research, LTD. · posted Oct 23, 2018 · Terminated
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010.… ↗Class I
Z-0188-2019 · Alcon Research, LTD. · posted Oct 23, 2018 · Terminated
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: ↗Class I
Z-0006-2019 · Endologix · posted Oct 3, 2018 · Terminated
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: ↗Class I
Z-0007-2019 · Endologix · posted Oct 3, 2018 · Terminated
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, ↗Class I
Z-0008-2019 · Endologix · posted Oct 3, 2018 · Terminated
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: ↗Class I
Z-0009-2019 · Endologix · posted Oct 3, 2018 · Terminated
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeriesClass I
Z-2970-2018 · Pro-Med Instruments Gmbh · posted Sep 17, 2018 · Terminated
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous…Class I
Z-2971-2018 · Pro-Med Instruments Gmbh · posted Sep 17, 2018 · Terminated
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous…Class I
Z-2972-2018 · Pro-Med Instruments Gmbh · posted Sep 17, 2018 · Terminated
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700Class I
Z-2996-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500Class I
Z-2997-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091Class I
Z-2998-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098Class I
Z-2999-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099Class I
Z-3000-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093.Class I
Z-3001-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097Class I
Z-3002-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135Class I
Z-3003-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501Class I
Z-3004-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ISH Protease 3, Catalog Number 05273331001, model 780-4149Class I
Z-3005-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model…Class I
Z-3006-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model…Class I
Z-3007-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092Class I
Z-3008-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010Class I
Z-3009-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015Class I
Z-3010-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
CINtec Histology (250), Catalog Number 06680011001, model 725-4793Class I
Z-3011-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 ↗Class I
Z-3012-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713Class I
Z-3013-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 ↗Class I
Z-3014-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 ↗Class I
Z-3015-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ↗Class I
Z-3016-2018 · Ventana Medical Systems Inc · posted Sep 14, 2018 · Terminated
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General…Class I
Z-2817-2018 · bioMerieux, Inc. · posted Aug 30, 2018 · Terminated
The Tri-Flo Subglottic Suction System ↗Class I
Z-2826-2018 · Vyaire Medical · posted Aug 21, 2018 · Terminated
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ↗Class I
Z-2741-2018 · Compass Health Brands (Corporate Office) · posted Aug 20, 2018 · Terminated
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and…Class I
Z-2589-2018 · Spacelabs Healthcare, Ltd. · posted Aug 10, 2018 · Terminated
AirLife Resuscitation Device, Adult labeled as the following: ↗Class I
Z-2552-2018 · Vyaire Medical · posted Aug 8, 2018 · Terminated
AirLife Resuscitation Device, Pediatric labeled as the following: ↗Class I
Z-2553-2018 · Vyaire Medical · posted Aug 8, 2018 · Terminated
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA ↗Class I
Z-2577-2018 · Qiagen Sciences, Inc. · posted Jul 13, 2018 · Terminated
Draeger Jaundice Meter JM-103 ↗Class I
Z-2046-2018 · Draeger Medical Systems, Inc. · posted Jun 7, 2018 · Terminated
Draeger Jaundice Meter JM-105 ↗Class I
Z-2047-2018 · Draeger Medical Systems, Inc. · posted Jun 7, 2018 · Terminated
Heartware Medtronic HVAD System for cardiac use. Including the following parts:Class I
Z-1903-2018 · Heartware · posted May 21, 2018 · Open, Classified
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3Class I
Z-1774-2018 · Abbott · posted May 17, 2018 · Terminated
MindFrame Capture LP Revascularization Devices: Product Numbers:Class I
Z-1701-2018 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · posted May 16, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag ↗Class I
Z-1547-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ↗Class I
Z-1548-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer ↗Class I
Z-1549-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter ↗Class I
Z-1550-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer ↗Class I
Z-1551-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ↗Class I
Z-1552-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter ↗Class I
Z-1553-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve ↗Class I
Z-1554-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter ↗Class I
Z-1555-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer ↗Class I
Z-1556-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor ↗Class I
Z-1557-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor,… ↗Class I
Z-1558-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer ↗Class I
Z-1559-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow ↗Class I
Z-1560-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector,… ↗Class I
Z-1561-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing ↗Class I
Z-1562-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1563-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1564-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve ↗Class I
Z-1565-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve ↗Class I
Z-1566-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1567-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ↗Class I
Z-1568-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve ↗Class I
Z-1569-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve ↗Class I
Z-1570-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve ↗Class I
Z-1571-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve ↗Class I
Z-1572-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve ↗Class I
Z-1573-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve ↗Class I
Z-1574-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve ↗Class I
Z-1575-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow ↗Class I
Z-1576-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Broselow Hinkle Kit ↗Class I
Z-1577-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Broselow Hinkle Kit ↗Class I
Z-1578-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Replacement kit for outer shell, Broselow ↗Class I
Z-1579-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve ↗Class I
Z-1580-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve ↗Class I
Z-1581-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
Fabius MRI, anesthesia machine, catalog no. 8607300Class I
Z-1481-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
Fabius GS Premium, anesthesia machine, catalog no. 8607000 ↗Class I
Z-1482-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
Fabius Tiro, anesthesia machine, catalog no. 8606000 ↗Class I
Z-1483-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
Fabius Tiro M, anesthesia machine, catalog no. 8608400 ↗Class I
Z-1484-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
6F Taiga Guiding CatheterClass I
Z-1207-2018 · Medtronic Inc · posted Mar 29, 2018 · Terminated
BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011)Class I
Z-1139-2018 · Becton Dickinson & Company · posted Mar 22, 2018 · Terminated
BD Vacutainer EDTA Tan Top Tube ↗Class I
Z-1140-2018 · Becton Dickinson & Company · posted Mar 22, 2018 · Terminated
BD Vacutainer EDTA Pink Top TubeClass I
Z-1141-2018 · Becton Dickinson & Company · posted Mar 22, 2018 · Terminated
BD Vacutainer Lithium Heparin Green Top TubeClass I
Z-1142-2018 · Becton Dickinson & Company · posted Mar 22, 2018 · Terminated
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. ↗Class I
Z-0194-2018 · Monteris Medical Corp · posted Mar 20, 2018 · Terminated
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnosticClass I
Z-0729-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnosticClass I
Z-0730-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnosticClass I
Z-0731-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic ↗Class I
Z-0732-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnosticClass I
Z-0733-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic ↗Class I
Z-0734-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic ↗Class I
Z-0735-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnosticClass I
Z-0736-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnosticClass I
Z-0737-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnosticClass I
Z-0738-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnosticClass I
Z-0739-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic ↗Class I
Z-0740-2018 · Ventana Medical Systems Inc · posted Feb 27, 2018 · Terminated
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ↗Class I
Z-0489-2018 · Philips North America, LLC · posted Feb 8, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following:Class I
Z-0582-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following:Class I
Z-0583-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following:Class I
Z-0584-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following:Class I
Z-0585-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following:Class I
Z-0586-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following:Class I
Z-0587-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following:Class I
Z-0588-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as:Class I
Z-0589-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 1, 2018 · Terminated
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model… ↗Class I
Z-0343-2018 · Vyaire Medical · posted Jan 24, 2018 · Terminated
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model… ↗Class I
Z-0344-2018 · Vyaire Medical · posted Jan 24, 2018 · Terminated
Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. ↗Class I
Z-0345-2018 · Vyaire Medical · posted Jan 24, 2018 · Terminated
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. ↗Class I
Z-0346-2018 · Vyaire Medical · posted Jan 24, 2018 · Terminated
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 ↗Class I
Z-0294-2018 · Physio-Control, Inc. · posted Jan 11, 2018 · Terminated
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29AClass I
Z-0293-2018 · Edwards Lifesciences, LLC · posted Jan 10, 2018 · Terminated

About this data

Unit: a recall record is one product in an FDA recall (one recall number, e.g. Z-1234-2018). A recall event can include several products.
Date: records are counted by the date the FDA posted them, not the date the company started the recall.
Class: from FDA enforcement reports. Records without a class have not been classified yet.
Limits: recall counts do not measure how safe a device or company is. Companies with many products, kits or proactive quality systems can have more recalls. How recalls work.
Sources: FDA Medical Device Recalls database and FDA enforcement reports, via openFDA. Methodology.

Citing this report: “Device Safety Index, Medical Device Recalls in 2018, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.