Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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Date	Product	Reason	Class	Firm
Sep 23, 2015	Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset,...	Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.	Class II	Exactech, Inc.
Sep 23, 2015	Ventilator Tubing	As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product reca...	Class II	Instrumentation Industries Inc
Sep 23, 2015	HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45c...	Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.	Class II	Ethicon Endo-Surgery Inc
Sep 23, 2015	MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UP...	GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Op...	Class II	GE Medical Systems, LLC
Sep 22, 2015	Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi...	Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject...	Class II	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Sep 22, 2015	Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that i...	Possible for sample tubes in the loader to be opened and contaminate the system as well as adjace...	Class II	Roche Diagnostics Operations, Inc.
Sep 22, 2015	Eon 300 system includes the following product reference numbers and names: ...	ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system...	Class II	ELITech Clinical Systems SAS
Sep 22, 2015	Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia mea...	Results for ammonia are below the linear range of the assay for samples that have been collected ...	Class II	Sentinel CH SpA
Sep 22, 2015	Merge Cardio software. Product Usage: Merge Cardio is a system intended...	Users can merge a device import file with an image study that already has a confirmed report, whi...	Class II	Merge Healthcare, Inc.
Sep 22, 2015	Envoy 500 system includes the following product reference numbers and names: ...	ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument syst...	Class II	ELITech Clinical Systems SAS
Sep 22, 2015	Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the...	For sites using the Issuer of Patient ID (IPID), the system will display the study list and image...	Class II	Merge Healthcare, Inc.
Sep 22, 2015	Eon 100 system included the following product reference numbers and names: ...	ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system...	Class II	ELITech Clinical Systems SAS
Sep 22, 2015	ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems ...	ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM sy...	Class II	ELITech Clinical Systems SAS
Sep 21, 2015	BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC...	Inadequate biocompatibility testing.	Class II	Biomet 3i, LLC
Sep 21, 2015	BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, ...	Inadequate biocompatibility testing.	Class II	Biomet 3i, LLC
Sep 21, 2015	Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. ...	Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the ...	Class II	Synthes (USA) Products LLC
Sep 21, 2015	Digital Lightbox, BrainLAB system, image processing, radiological Product ...	Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.	Class II	Brainlab AG
Sep 21, 2015	Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib...	Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants...	Class II	Stryker Howmedica Osteonics Corp.
Sep 21, 2015	BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC6...	Inadequate biocompatibility testing.	Class II	Biomet 3i, LLC
Sep 21, 2015	BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654,...	Inadequate biocompatibility testing.	Class II	Biomet 3i, LLC
Sep 21, 2015	Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator,...	The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is ...	Class II	Valeant Pharmacueticals International
Sep 21, 2015	TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indica...	One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (tota...	Class II	Biocompatibles U.K., Ltd.
Sep 21, 2015	Custom Pak 9319-27. Single-use medical devices and accessories designed by m...	The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than th...	Class II	Alcon Research, Ltd.
Sep 18, 2015	4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic cathete...	Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card...	Class II	Arrow International Inc
Sep 17, 2015	Philips DuraDiagnost stationary X-ray system	Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which ca...	Class II	Philips Electronics North America Corporation
Sep 17, 2015	Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ...	Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi...	Class II	Boston Scientific Corporation
Sep 17, 2015	Disposable Paper Filter for Sterilization Containers Paper, Medical Access...	Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise ...	Class II	Stryker Craniomaxillofacial Division
Sep 16, 2015	Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For us...	The labeling is missing the size/diameter information.	Class II	Encore Medical, Lp
Sep 16, 2015	BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartrid...	May report values outside the published performance specifications for pH. After a certain point...	Class II	LifeHealth, LLC
Sep 16, 2015	CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartri...	May report values outside the published performance specifications for pH. After a certain point...	Class II	LifeHealth, LLC
Sep 16, 2015	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha...	Images may be missing when a system parameter MapRoute is set to a value greater than 1.	Class II	GE Healthcare
Sep 15, 2015	Monaco Radiation Treatment Planning System. Used to make treatment plans f...	Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple presc...	Class II	Elekta, Inc.
Sep 15, 2015	Medtronic Medical Device Identification Card for SureScan pacemaker patients....	Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Sep 15, 2015	AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba...	Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ...	Class II	Encore Medical, Lp
Sep 14, 2015	Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates an...	Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120...	Class II	Synthes (USA) Products LLC
Sep 14, 2015	Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size A...	SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per qual...	Class II	Valeant Pharmaceuticals North America LLC
Sep 14, 2015	P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024...	Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d...	Class II	Medtronic Navigation, Inc.
Sep 14, 2015	MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ...	The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin...	Class III	CooperSurgical, Inc.
Sep 14, 2015	Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon ...	During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Imp...	Class II	Encore Medical, Lp
Sep 14, 2015	Samsung GM60A-40S Intended for use in generating radiographic images of hu...	When the system is driving over a non-conductive floor and then over a conductive, grounded part,...	Class II	NeuroLogica Corporation
Sep 14, 2015	CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Pr...	CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels wh...	Class III	Biochemical Diagnostics Inc
Sep 14, 2015	Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction ...	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form t...	Class II	Encore Medical, Lp
Sep 14, 2015	Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce c...	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) Inc
Sep 14, 2015	Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross...	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) Inc
Sep 14, 2015	P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVE...	Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d...	Class II	Medtronic Navigation, Inc.
Sep 14, 2015	PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF...	The label on the lid stock of the individual needle packages for a portion of Lot number 46262 co...	Class II	Smiths Medical ASD, Inc.
Sep 14, 2015	Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems....	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) Inc
Sep 14, 2015	Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to pro...	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) Inc
Sep 14, 2015	Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-...	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) Inc
Sep 14, 2015	Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-s...	The firm discovered Ring/Dot artifact due to X-ray measurement error.	Class II	Philips Medical Systems (Cleveland) 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.