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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 4, 2017 | RESONATE EL ICD DR, Model D433, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | MOMENTUM X4 CRT-D, Model G138, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE EL ICD VR, Model D432, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE X4 CRT-D, Model G447, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used... | Non-Conforming devices were shipped from the service center without proper evaluation and therefo... | Class II | GE Healthcare, LLC |
| Oct 3, 2017 | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is e... | HighPuragar was mislabeled and inadvertently sold as Noble Agar. | Class II | Becton Dickinson & Co. |
| Oct 3, 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| Oct 3, 2017 | Flexible Shaft hip and anatomical shoulder instrument used for preparation of... | The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... | Class II | Zimmer Biomet, Inc. |
| Oct 3, 2017 | Sirus Drill 13mm diameter trauma instrument used for preparation of bone in T... | The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... | Class II | Zimmer Biomet, Inc. |
| Oct 3, 2017 | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arth... | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70... | Class II | Zimmer Biomet, Inc. |
| Oct 3, 2017 | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR ... | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UF... | Class II | Arthrex, Inc. |
| Oct 3, 2017 | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. ... | The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were ... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Oct 2, 2017 | SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 110... | The table may become unstable if the nuts on the bolts were not adequately tightened and thus hav... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Oct 2, 2017 | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 1106... | The table may become unstable if the nuts on the bolts were not adequately tightened and thus hav... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 30, 2017 | O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... | During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 30, 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... | Product was released to market without the adulteration strip included in the product. | Class III | Ameditech Inc |
| Sep 29, 2017 | Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Numb... | Knee implant components (tibial bearings) are labeled with the incorrect size. | Class II | Zimmer Biomet, Inc. |
| Sep 29, 2017 | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter... | The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Sep 29, 2017 | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 29, 2017 | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M ... | The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may le... | Class II | C.R. Bard, Inc. |
| Sep 29, 2017 | OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/atta... | This voluntary recall was initiated because a veterinary unit was physically shipped in error to ... | Class II | The Anspach Effort, Inc. |
| Sep 29, 2017 | Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, It... | Knee implant components (tibial bearings) are labeled with the incorrect size. | Class II | Zimmer Biomet, Inc. |
| Sep 29, 2017 | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 28, 2017 | AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay... | The firm has become aware of a potential issue that may affect the mixing motor drive harness and... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2017 | Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Mo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... | Class II | Steris Corporation |
| Sep 28, 2017 | Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will... | Class II | Philips Electronics North America Corporation |
| Sep 28, 2017 | FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Can... | A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharpe... | Class II | Sorin Group USA, Inc. |
| Sep 28, 2017 | Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot swit... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Pow... | Users manuals not supplied with 4800-00T US Rapid Therapy System | Class II | The Magstim Company Limited |
| Sep 28, 2017 | Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Lu... | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expr... | Class II | Cosmedent, Inc. |
| Sep 27, 2017 | Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR... | There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirm... | Class II | WalkMed, LLC |
| Sep 26, 2017 | 6F Taiga Guiding Catheter | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | Class I | Medtronic Inc |
| Sep 26, 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ i... | If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is ... | Class II | Mobius Imaging, LLC |
| Sep 26, 2017 | Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; C... | A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two ... | Class II | Integra LifeSciences Corp. |
| Sep 25, 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the v... | The observed issues can lead to unexpected interruptions of the optics carrier focus drive moveme... | Class II | Leica Microsystems, Inc. |
| Sep 25, 2017 | CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. No... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 25, 2017 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented ... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 25, 2017 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvente... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 25, 2017 | Regard Custom Surgical Pack Packs contain surgical instruments and accesso... | Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect l... | Class II | Resource Optimization & Innovation Llc |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r... | Class III | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 25, 2017 | GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic End... | Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. | Class II | W L Gore & Associates, Inc. |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individu... | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... | Class II | Circulatory Technology Inc |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO | Leaks complaints. | Class II | Guangzhou Improve Medical Instruments Co., Ltd. |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
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.