Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 22, 2017 | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-... | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b... | Class III | Euro Diagnostica AB |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 19, 2017 | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Mul... | Software defect | Class II | Neusoft Medical Systems Co., Ltd. |
| May 19, 2017 | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: Neu... | Software defect | Class II | Neusoft Medical Systems Co., Ltd. |
| Apr 28, 2017 | Monica Novii Wireless Patch System product Usage: Novii Interface - The N... | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged cha... | Class II | MONICA HEALTHCARE LTD |
| Apr 25, 2017 | MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system th... | A system component overheated causing melting of the connector and emission of smoke through the ... | Class II | Medistim Asa |
| Apr 18, 2017 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator... | ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR... | Class II | ELITech Clinical Systems SAS |
| Apr 13, 2017 | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an elec... | Software bug which allows parameters to be changed unintentionally during use. | Class II | CardioTek BV |
| Apr 12, 2017 | Savaria SL-1000 Stairlift | The electrical controller, combined with motor, causes feedback, damaging a component on the cont... | Class II | Savaria Concord Lifts, Inc. |
| Apr 12, 2017 | The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for ... | Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product def... | Class II | Savaria Concord Lifts, Inc. |
| Apr 12, 2017 | Omega Incline Platform Lift | Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift ... | Class II | Savaria Concord Lifts, Inc. |
| Mar 30, 2017 | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. ... | If metal strips are removed and re-applied to another display, there is potential for the metal s... | Class II | Barco N.V. |
| Mar 21, 2017 | Proteus 235, Proton Therapy System | In specific circumstances, the user is able to restart an aborted irradiation without having to s... | Class II | Ion Beam Applications S.A. |
| Mar 17, 2017 | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) as... | Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated e... | Class II | BioMerieux SA |
| Mar 14, 2017 | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS Sys... | Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... | Class II | Nexstim PLC |
| Mar 14, 2017 | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigat... | Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... | Class II | Nexstim PLC |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Mar 7, 2017 | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be ... | Problem with colored eluates for whole blood extractions | Class II | BioMerieux SA |
| Mar 7, 2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 215... | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagen... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Mar 1, 2017 | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for t... | Aluminum pouch seal was noticed to be defective (slightly open). | Class II | Inion Ltd. |
| Feb 27, 2017 | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US in... | Class II | CORENTEC CO., LTD |
| Feb 20, 2017 | SmartTools Knee System Orthopedic Stereotaxic Instrument | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Feb 15, 2017 | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Caps... | When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was d... | Class II | IntroMedic Co., Ltd. |
| Feb 14, 2017 | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (an... | Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200)... | Class II | Euro Diagnostica AB |
| Feb 8, 2017 | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous... | Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting dow... | Class II | Del Mar Reynolds Medical, Ltd. |
| Jan 31, 2017 | Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Ster... | Product sterility compromised due to breach of sterile barrier | Class II | Degania Silicone, Ltd. |
| Jan 30, 2017 | Hidrex USA DP450 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | Hidrex USA DVP1000 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | Daavlin Aquex (DAAV1000) | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 18, 2017 | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 18, 2017 | ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is... | Potential performance issues. False Susceptible result instead of Intermediate and False Interme... | Class II | BioMerieux SA |
| Jan 13, 2017 | Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: ... | Distribution of unapproved devices with incorrect air compression level setup | Class II | Won Industry Co. |
| Jan 13, 2017 | Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air ... | Distribution of unapproved devices with incorrect air compression level setup | Class II | Won Industry Co. |
| Jan 11, 2017 | VIDAS 3 software v. 1.1.4 | During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o... | Class II | BioMerieux SA |
| Jan 11, 2017 | L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, F... | Firm received a complaint of the tip holder breaking during use. | Class II | Kiscomedica S.A. |
| Jan 5, 2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 5, 2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 3, 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Stryker Leibinger GmbH & Co. KG |
| Jan 3, 2017 | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Stryker Leibinger GmbH & Co. KG |
| Dec 27, 2016 | Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray... | Patient fell from the table because the footrest of the device detached from the table top while ... | Class II | Villa Sistemi Medicali S.P.A. |
| Dec 27, 2016 | Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ra... | Patient fell from the table because the footrest of the device detached from the table top while ... | Class II | Villa Sistemi Medicali S.P.A. |
| Dec 27, 2016 | Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9... | Patient fell from the table because the footrest of the device detached from the table top while ... | Class II | Villa Sistemi Medicali S.P.A. |
| Dec 27, 2016 | Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray syst... | Patient fell from the table because the footrest of the device detached from the table top while ... | Class II | Villa Sistemi Medicali S.P.A. |
| Dec 23, 2016 | Optilite IgG4 Kit Product Code: LK009.OPT.A | A change to the lower end of the measuring range and product insert did not reflect the change.Th... | Class III | The Binding Site Group, Ltd. |
| Dec 13, 2016 | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst... | Software issue | Class II | Ion Beam Applications S.A. |
| Dec 7, 2016 | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small S... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The prod... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem ... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small S... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
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.