Medical DeviceOct 29, 2014
Signal Medical Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee recall — FDA Z-0111-2015
Packaging of a device was compromised
Class IIFDA: TerminatedSignal Medical Corporation
30,447medical device recall records
2,766FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1254
30,447 detailed records are currently available in this category.
Medical DeviceOct 29, 2014
Siemens Healthcare Diagnostics IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog recall — FDA Z-0122-2015
Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics
Medical DeviceOct 29, 2014
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A recall — FDA Z-0105-2015
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceOct 29, 2014
Aerogen The Aeroneb Professional Nebulizer System is a portable medical device for multiple recall — FDA Z-0119-2015
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints…
Class IIFDA: TerminatedAerogen Ltd.
Medical DeviceOct 22, 2014
Merge Healthcare eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components recall — FDA Z-0068-2015
There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceOct 22, 2014
Covidien Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes recall — FDA Z-0044-2015
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Class IFDA: TerminatedCovidien LLC
Medical DeviceOct 22, 2014
KCI USA V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may recall — FDA Z-0070-2015
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of…
Class IIFDA: TerminatedKCI USA, Inc.
Medical DeviceOct 22, 2014
Ameditech ArcPoint Labs 10 Panel Dip Screen (BAR), Part No recall — FDA Z-0072-2015
Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the…
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceOct 22, 2014
Arjo, Inc. dba ArjoHuntleigh Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes recall — FDA Z-0079-2015
The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the…
Class IIFDA: TerminatedArjo, Inc. dba ArjoHuntleigh
Medical DeviceOct 22, 2014
Baxter Healthcare 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing recall — FDA Z-0080-2015
The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
Class IIFDA: TerminatedBaxter Healthcare Corp
Medical DeviceOct 22, 2014
Arrow International Multi-Lumen Central Venous Catheterization Kit recall — FDA Z-0076-2015
Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceOct 22, 2014
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes recall — FDA Z-0043-2015
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
Class IFDA: TerminatedCovidien LLC
Medical DeviceOct 22, 2014
Intuitive Surgical EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si recall — FDA Z-0063-2015
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceOct 22, 2014
Intuitive Surgical EndoWrist Stapler 45 instrument for the da Vinci Si System recall — FDA Z-0074-2015
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceOct 22, 2014
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006 recall — FDA Z-0046-2015
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Class IFDA: TerminatedCovidien LLC
Medical DeviceOct 22, 2014
Ortho-Clinical Diagnostics VITROS 4600 Chemistry System recall — FDA Z-0077-2015
Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceOct 22, 2014
Ameditech ArcPoint Labs 10 Panel Dip Screen (OXY), Part No recall — FDA Z-0073-2015
Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the…
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceOct 22, 2014
Roche Diagnostics Operations Omni Micro-electrode/reference electrode for cobas b221 recall — FDA Z-0064-2015
The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with…
Class IIIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceOct 22, 2014
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush recall — FDA Z-0066-2015
The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceOct 22, 2014
Covidien MediChoice Multifunction Electrode Part Number: MC171 OH recall — FDA Z-0047-2015
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Class IFDA: TerminatedCovidien LLC
Medical DeviceOct 22, 2014
Covidien Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A recall — FDA Z-0048-2015
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Class IFDA: TerminatedCovidien LLC
Medical DeviceOct 22, 2014
Biomet Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow recall — FDA Z-0075-2015
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceOct 22, 2014
Primus Medical AC Powered adjustable bed frame recall — FDA Z-0067-2015
Firm received several complaints that the head deck actuator bracket had separated from the bed frame.
Class IIFDA: TerminatedPrimus Medical LLC
Medical DeviceOct 22, 2014
Siemens Healthcare Diagnostics External power supply adaptors that accompany Clinitek recall — FDA Z-0081-2015
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
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.