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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DateProductReasonClassFirm
Mar 25, 2016 Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health ... BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... Class II Becton Dickinson & Company
Mar 25, 2016 AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500... Under certain conditions, mass spectrometers may report incorrect quantitative results. Class II Ab Sciex
Mar 25, 2016 The Plum 360 is a large volume infuser capable of delivering fluids for a var... Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... Class II Hospira Inc.
Mar 25, 2016 Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by heal... BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... Class II Becton Dickinson & Company
Mar 25, 2016 The Plum A+ is a dual-line volumetric infusion system designed to meet the gr... Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... Class II Hospira Inc.
Mar 25, 2016 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi syst... Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software... Class II Intuitive Surgical, Inc.
Mar 25, 2016 Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. ... Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose a... Class II Hansen Medical Inc
Mar 25, 2016 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO... Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT proced... Class I Monteris Medical Corp
Mar 24, 2016 Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, ... The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the s... Class II CareFusion 303, Inc.
Mar 24, 2016 Ingenuity Core Computed Tomography X-ray systems is intended to produce cross... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematolo... Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality ... Class II Abbott Laboratories
Mar 24, 2016 NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body comput... The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version... Class II Philips and Neusoft Medical Systems Co., Ltd.
Mar 24, 2016 Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produ... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is ... Incorrect expiration date was printed on the product label. Class II Teleflex Medical
Mar 24, 2016 Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For... Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delay... Class II Remel Inc
Mar 24, 2016 Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to p... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce c... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to pr... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Dimension Vista 1500 Intelligent Lab System running on software versions V.3.... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II Siemens Healthcare Diagnostics Inc.
Mar 24, 2016 Dimension Vista 500 Intelligent Lab System running on software versions V.3.6... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II Siemens Healthcare Diagnostics Inc.
Mar 24, 2016 The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic ... Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estrad... Class II Abbott Laboratories
Mar 23, 2016 Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel... Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016.... Class III Acumedia Manufacturers, Inc.
Mar 22, 2016 SOMATOM Definition AS, a family of CT systems intended to produce cross-secti... Siemens became aware that the front cover on some Siemens CT system was not properly welded. It ... Class II Siemens Medical Solutions USA, Inc
Mar 22, 2016 Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 30... Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 ca... Class II Coloplast Manufacturing US, LLC
Mar 22, 2016 AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9... During an FDA inspection it was found that the products are marketed without a cleared 510k. Class II Medscience Inc
Mar 22, 2016 Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. ... Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lot... Class II Leica Microsystems, Inc.
Mar 22, 2016 Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... Class I Boston Scientific Corporation
Mar 22, 2016 Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw ... The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembl... Class II Stryker Instruments Div. of Stryker Corporation
Mar 21, 2016 AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016 Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom conven... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and det... Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GB... Class II Hardy Diagnostics
Mar 21, 2016 Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016 General Surgery Pack, part number 006880-3. This is a custom convenience sur... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 21, 2016 SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model nu... The affected scanner does not correctly interact with the SC360 software. When docked pre/postope... Class II Stryker Instruments Div. of Stryker Corporation
Mar 21, 2016 Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenien... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 18, 2016 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 1... The device may have a defect in the catheter. In some instances this defect could result in cathe... Class II Becton Dickinson & Company
Mar 18, 2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm... Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm di... Class II Boston Scientific Corporation
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Mar 18, 2016 RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common ... Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip ... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Mar 17, 2016 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: LDL Cholesterol, Direct Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Assays: Uric Acid (URCA) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Advia Chemistry Assay: Lactate Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Dimension Vista Assays: Enzymatic Creatine (ECRE) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,... It has been discovered that replacement x-ray generator and system motion batteries could become ... Class II Medtronic Navigation, Inc.-Littleton
Mar 17, 2016 Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Chol... Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... Class II Siemens Healthcare Diagnostics, 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.