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
Sep 18, 2017	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERIL...	The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead...	Class II	MicroPort Orthopedics Inc.
Sep 18, 2017	Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Inte...	The torque wrench used to tighten system bolts during installation was found to be out of tolerance	Class II	Siemens Medical Solutions USA, Inc.
Sep 18, 2017	BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for In...	Increased amount of residual blood present on the top of stopper well after venipuncture	Class II	Becton Dickinson & Company
Sep 15, 2017	Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial r...	The device cartridge disengaged during use due to manufacturing error.	Class II	Covidien LLC
Sep 15, 2017	Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reve...	Customers have reported a higher than expected number of invalid test results when using the reca...	Class II	Cepheid
Sep 15, 2017	EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERIL...	It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.	Class II	Encore Medical, Lp
Sep 15, 2017	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In...	An incorrect incubator was installed on one Panther System which potentially led to incorrect Apt...	Class II	Hologic, Inc
Sep 15, 2017	36MM COCR MODULAR HD -6MM	One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset ins...	Class II	Zimmer Biomet, Inc.
Sep 15, 2017	Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b...	Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i...	Class II	HILL-ROM MANUFACTURING, INC.
Sep 15, 2017	EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE ...	It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.	Class II	Encore Medical, Lp
Sep 14, 2017	Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Sep 14, 2017	smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL W...	The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.	Class II	Smith & Nephew, Inc.
Sep 14, 2017	Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy sys...	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la...	Class II	Cardiovascular Systems Inc
Sep 14, 2017	Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, ...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Sep 14, 2017	HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box,...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Sep 14, 2017	Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy sys...	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la...	Class II	Cardiovascular Systems Inc
Sep 13, 2017	Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal...	Potential for failure of the device safety interlock. The safety interlock prevents an empty sing...	Class II	Covidien LLC
Sep 13, 2017	Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-...	Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o...	Class II	Zimmer Biomet, Inc.
Sep 13, 2017	Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H...	It was determined that the deflection length indicated on the Guide catheter handle does not matc...	Class II	Medtronic Vascular, Inc.
Sep 13, 2017	SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 587...	The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The ...	Class II	The Metrix Company
Sep 13, 2017	979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.	Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o...	Class II	Zimmer Biomet, Inc.
Sep 13, 2017	14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument	Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o...	Class II	Zimmer Biomet, Inc.
Sep 12, 2017	i-STAT DE handheld data processing module for clinical use, Software Version ...	Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis...	Class II	Abbott Point Of Care Inc.
Sep 12, 2017	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is ...	During an examination images were displayed on the live monitor,but the images were not displayed...	Class II	Toshiba American Medical Systems Inc
Sep 12, 2017	Proclaim DRG Implantable Pulse Generator Model 3664	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	OTTO BOCK Kenevo knee joints Model 3C60	Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes...	Class II	Otto Bock Healthcare Product
Sep 12, 2017	Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Prod...	The tucking depth feature of this catheter introducer is marginally outside the upper specification.	Class II	Terumo Medical Corporation
Sep 12, 2017	OTTO BOCK Kenevo knee joints Model 3C60=ST	Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes...	Class II	Otto Bock Healthcare Product
Sep 12, 2017	LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. Th...	Incorrect service code for properly catching critical defects during self-check. Potential for de...	Class II	Zoll Manufacturing Corp.
Sep 12, 2017	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 11, 2017	BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and syn...	Cut resistant surgical glove liners lack sterility assurance.	Class II	Zimmer Biomet, Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 8, 2017	JS Series SterilContainer S2 System	The JS Series SterilContainer S2 System was released to the market place prior to an authorized F...	Class II	Aesculap Implant Systems LLC
Sep 8, 2017	Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a dil...	There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) res...	Class II	Sysmex America, Inc.
Sep 8, 2017	Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during i...	An internal analysis on complaints received indicated that the welding process may have been perf...	Class II	Limacorporate S.p.A
Sep 8, 2017	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered	During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap ...	Class II	Handicare Usa Inc
Sep 8, 2017	AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the ...	When the lever of the Insertion Handle is in the "locked" position, the implant may be able to p...	Class II	Howmedica Osteonics Corp.
Sep 7, 2017	The 2nd Assist Knee Positioner	Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to ...	Class II	Zimmer Biomet, Inc.
Sep 7, 2017	AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood ga...	Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give i...	Class II	Radiometer America Inc
Sep 6, 2017	THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-13270...	Biosense Webster, Inc. has recently received an increased number of complaints related to the dis...	Class II	Biosense Webster, Inc.
Sep 6, 2017	THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-...	Biosense Webster, Inc. has recently received an increased number of complaints related to the dis...	Class II	Biosense Webster, Inc.
Sep 6, 2017	THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)	Biosense Webster, Inc. has recently received an increased number of complaints related to the dis...	Class II	Biosense Webster, Inc.
Sep 6, 2017	THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02...	Biosense Webster, Inc. has recently received an increased number of complaints related to the dis...	Class II	Biosense Webster, Inc.
Sep 6, 2017	THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S,...	Biosense Webster, Inc. has recently received an increased number of complaints related to the dis...	Class II	Biosense Webster, Inc.
Sep 5, 2017	Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.	Class I	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...

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.