Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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Date	Product	Reason	Class	Firm
Oct 27, 2016	Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image ...	Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific seri...	Class II	Brainlab AG
Oct 27, 2016	LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Produc...	Product Defect; These products may produce a straight stream instead of a fully atomized plume of...	Class II	Teleflex Medical
Oct 27, 2016	LMA MADdy, Rx only, Product Usage: These products are used for the deliv...	Product Defect; These products may produce a straight stream instead of a fully atomized plume of...	Class II	Teleflex Medical
Oct 27, 2016	LMA MADomizer, Rx only, Product Usage: These products are used for the d...	Product Defect; These products may produce a straight stream instead of a fully atomized plume of...	Class II	Teleflex Medical
Oct 27, 2016	Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with ...	Product Defect; These products may produce a straight stream instead of a fully atomized plume of...	Class II	Teleflex Medical
Oct 26, 2016	Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intende...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer...	3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces...	Class II	3M Company - Health Care Business
Oct 26, 2016	VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per ...	CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products ...	Class III	Ortho-Clinical Diagnostics
Oct 26, 2016	Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Inten...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intende...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intend...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facil...	Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha...	Class II	Atrium Medical Corporation
Oct 26, 2016	Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the qu...	There may be a loss of separation between Calibrators A and B which may impact the assay calibrat...	Class III	Diagnostic Hybrids, Inc.
Oct 25, 2016	ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non...	DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due...	Class II	Depuy Orthopaedics Inc.
Oct 25, 2016	Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit	Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.	Class II	Exactech, Inc.
Oct 25, 2016	Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system wit...	Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been ...	Class II	Toshiba American Medical Systems Inc
Oct 25, 2016	NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reo...	Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incor...	Class II	Smiths Medical ASD, Inc.
Oct 25, 2016	SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Ca...	Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to th...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 25, 2016	OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 19097...	Trumpf has identified six incidents of pinched cables.	Class II	Trumpf Medical Systems, Inc.
Oct 25, 2016	MicroScan LabPro Data Management System. Intended to manage both microbial...	Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior whe...	Class II	Beckman Coulter Inc.
Oct 24, 2016	Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access O...	Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not...	Class II	Beckman Coulter Inc.
Oct 24, 2016	Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd...	Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Late...	Class II	Ansell Healthcare Products LLC
Oct 24, 2016	FMsealer Open Shears. Model FM3001	Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixe...	Class II	Domain Surgical, Inc.
Oct 24, 2016	Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The A...	Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not...	Class II	Beckman Coulter Inc.
Oct 21, 2016	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t...	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.	Class III	Euro Diagnostica AB
Oct 21, 2016	MEVION S250 Product Usage: Proton Radiation Therapy System	Recovery of Incorrect Isocenter -operational change	Class II	Mevion Medical Systems, Inc.
Oct 21, 2016	is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assa...	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.	Class III	Euro Diagnostica AB
Oct 21, 2016	ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.	Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens rec...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 21, 2016	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t...	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.	Class III	Euro Diagnostica AB
Oct 21, 2016	is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t...	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.	Class III	Euro Diagnostica AB
Oct 21, 2016	Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Mul...	The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to r...	Class I	Centurion Medical Products Corporation
Oct 21, 2016	5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artif...	The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause...	Class I	SynCardia Systems Inc.
Oct 20, 2016	NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cass...	Incorrect hCG results	Class II	Ekla Corporation
Oct 20, 2016	Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a...	A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio...	Class II	Merge Healthcare, Inc.
Oct 20, 2016	Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S...	The sterile packaging may contain small channels in the seal of the pouch, If the channels are p...	Class II	Micromedics, Inc.
Oct 20, 2016	SOMATOM Force, System x-ray, tomography, computed	Siemens is providing software update version VA50A_SP3 to address the software bugs that were i...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2016	MEVION S250 Product Usage: Proton Radiation Therapy System	Software defect:2D projection of contours in Verity. The defect causes structures to appear off f...	Class II	Mevion Medical Systems, Inc.
Oct 19, 2016	Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO ...	Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the...	Class II	Guangzhou Improve Medical Instruments Co., Ltd.
Oct 19, 2016	SOMATOM Definition Flash system, x-ray, tomography, computed	Hardware issue that may expose the user to a potential risk for serious injury due to exposure to...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2016	Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usab...	On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints ...	Class II	Greatbatch Medical
Oct 19, 2016	Ultroid Sterile Disposable Probes sold individually	Products are not designed, qualified, manufactured, and/or managed under a state of control per i...	Class II	Ultroid Technologies, Inc.
Oct 19, 2016	SOMATOM Definition AS system, x-ray, tomography, computed	Hardware issue that may expose the User to a potential risk for serious injury due to exposure to...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2016	AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing ...	Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased gene...	Class II	Beckman Coulter Inc.
Oct 19, 2016	SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM ...	A problem can occur with the small light marker windows, used for the positioning laser and are i...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2016	Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile ...	Products are not designed, qualified, manufactured, and/or managed under a state of control per i...	Class II	Ultroid Technologies, Inc.
Oct 19, 2016	ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur an...	CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A...	Class II	Siemens Healthcare Diagnostics, Inc
Oct 19, 2016	Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.	Products are not designed, qualified, manufactured, and/or managed under a state of control per i...	Class II	Ultroid Technologies, 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.