Medical DeviceSep 24, 2014
Bio-Detek ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ( recall — FDA Z-2659-2014
Sterility of device is not assured
Class IIFDA: TerminatedBio-Detek, Inc.
30,447medical device recall records
2,766FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1262
30,447 detailed records are currently available in this category.
Medical DeviceSep 24, 2014
Genesis BPS, LLC Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS recall — FDA Z-2669-2014
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Class IIFDA: TerminatedGenesis BPS, LLC.
Medical DeviceSep 24, 2014
Genesis BPS, LLC Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis recall — FDA Z-2667-2014
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Class IIFDA: TerminatedGenesis BPS, LLC.
Medical DeviceSep 24, 2014
Varian Medical Systems 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC recall — FDA Z-2654-2014
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's…
Class IIFDA: TerminatedVarian Medical Systems, Inc.
Medical DeviceSep 17, 2014
GE Healthcare CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE recall — FDA Z-2617-2014
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceSep 17, 2014
Baxter Healthcare ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip recall — FDA Z-2613-2014
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…
Class IIFDA: TerminatedBaxter Healthcare Corp
Medical DeviceSep 17, 2014
Life Force Chamber Product Usage:The product is intended for restful contemplation and recall — FDA Z-2625-2014
The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of…
Class IIFDA: TerminatedLife Force of Tampa, LLC
Medical DeviceSep 17, 2014
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to recall — FDA Z-2609-2014
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Class IIFDA: TerminatedAb Sciex
Medical DeviceSep 17, 2014
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary recall — FDA Z-2594-2014
Identifiers on the label are correct but the label has the incorrect color coding.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceSep 17, 2014
PIONEER SURGICAL TECHNOLOGY Streamline MIS Spinal Fixation System Fixed Rod Holder NON recall — FDA Z-2616-2014
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Class IIFDA: TerminatedPIONEER SURGICAL TECHNOLOGY, Inc.
Medical DeviceSep 17, 2014
Siemens Luminos dRF, Ysio or Uroskop Omnia systems recall — FDA Z-2292-2014
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 17, 2014
Ethicon Endo-Surgery PROXIMATE Skin Stapler recall — FDA Z-2610-2014
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Class IIFDA: TerminatedEthicon Endo-Surgery Inc.
Medical DeviceSep 17, 2014
Catheter Connections DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF recall — FDA Z-2595-2014
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
Class IIFDA: TerminatedCatheter Connections, Inc.
Medical DeviceSep 17, 2014
Wright Medical Technology CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF recall — FDA Z-2605-2014
Plates manufactured from an incorrect raw material.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceSep 17, 2014
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform recall — FDA Z-2611-2014
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Class IIFDA: TerminatedIllumina Inc.
Medical DeviceSep 17, 2014
Baxter Healthcare ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL recall — FDA Z-2615-2014
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…
Class IIFDA: TerminatedBaxter Healthcare Corp
Medical DeviceSep 17, 2014
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ recall — FDA Z-2570-2014
Unsealed pouches.
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceSep 17, 2014
Medtronic Cardiovascular Surgery-the Heart Valve Hancock Apical Left Ventricle Connector recall — FDA Z-2623-2014
Medtronic has decided to discontinue production and distribution of this low-volume product.
Class IIFDA: TerminatedMedtronic Cardiovascular Surgery-the Heart Valve…
Medical DeviceSep 17, 2014
Wright Medical Technology CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH recall — FDA Z-2600-2014
Plates manufactured from an incorrect raw material.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceSep 17, 2014
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product recall — FDA Z-2626-2014
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Class IIFDA: TerminatedStryker Spine
Medical DeviceSep 17, 2014
Integra Container Lid, ¿¿ Size, Red recall — FDA Z-2624-2014
Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently…
Class IIFDA: TerminatedIntegra York PA, Inc.
Medical DeviceSep 17, 2014
Wright Medical Technology CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF recall — FDA Z-2608-2014
Plates manufactured from an incorrect raw material.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceSep 17, 2014
Radiometer RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing recall — FDA Z-2597-2014
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE…
Class IIFDA: TerminatedRadiometer America Inc.
Medical DeviceSep 17, 2014
Becton Dickinson & Co The BD MAX MRSA Assay, catalogue #442953 recall — FDA Z-2618-2014
The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at…
Class IIFDA: TerminatedBecton Dickinson & Co.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.