Medical DeviceMay 4, 2016
Mako Surgical RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons recall — FDA Z-1583-2016
Potential disassociation of the orientation pin.
Class IIFDA: TerminatedMako Surgical Corporation
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1082
28,992 detailed records are currently available in this category.
Medical DeviceMay 4, 2016
Hansen Medical Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80 recall — FDA Z-1564-2016
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Class IIFDA: TerminatedHansen Medical Inc.
Medical DeviceMay 4, 2016
Becton, Dickinson and Company, BD Biosciences BD Trucount Absolute Counting Tubes recall — FDA Z-1570-2016
One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low…
Class IIFDA: TerminatedBecton, Dickinson and Company, BD Biosciences
Medical DeviceMay 4, 2016
3M Company - Health Care Business 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL recall — FDA Z-1563-2016
3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve…
Class IIFDA: Terminated3M Company - Health Care Business
Medical DeviceMay 4, 2016
Mindray DS USA, Inc. dba Mindray Panorama Patient Monitoring Network Mindray DS USA The recall — FDA Z-1575-2016
Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or…
Class IIFDA: TerminatedMindray DS USA, Inc. dba Mindray North America
Medical DeviceMay 4, 2016
Philips Visicu eCareCoordinator allows the customer to schedule patient tasks recall — FDA Z-1557-2016
The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14…
Class IIFDA: TerminatedPhilips Visicu
Medical DeviceMay 4, 2016
Synthes (USA) Products 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile recall — FDA Z-1574-2016
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceMay 4, 2016
Ortho-Clinical Diagnostics enGen (TM) Laboratory Automation System configured with Thermo recall — FDA Z-1569-2016
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 4, 2016
Intuitive Surgical EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi recall — FDA Z-1568-2016
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the…
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceMay 4, 2016
Siemens Medical Solutions USA ACUSON X700 Ultrasound System with software version 1.0.04 recall — FDA Z-1572-2016
Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 4, 2016
Stryker Endoscopy PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator recall — FDA Z-1566-2016
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red…
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceMay 4, 2016
Corin USA Trinity Acetabular System Product Usage - Total Hip Replacement recall — FDA Z-1526-2016
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Class IIFDA: TerminatedCorin USA Limited
Medical DeviceMay 4, 2016
Baxter Healthcare Automated peritoneal dialysis (APD) cycler recall — FDA Z-1565-2016
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating…
Class IIFDA: TerminatedBaxter Healthcare Corp.
Medical DeviceMay 4, 2016
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm recall — FDA Z-1567-2016
Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 4, 2016
Corin USA Trinity Acetabular Shell Product Usage Total Hip Replacement recall — FDA Z-1528-2016
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Class IIFDA: TerminatedCorin USA Limited
Medical DeviceMay 4, 2016
Elekta Radionuclide Radiation Therapy System Product The product is a teletherapy device recall — FDA Z-1561-2016
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceMay 4, 2016
Philips and Neusoft Medical Systems Co NeuViz 16 Multi-Slice CT Scanner System PN recall — FDA Z-1573-2016
The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard…
Class IIFDA: TerminatedPhilips and Neusoft Medical Systems Co., Ltd.
Medical DeviceMay 4, 2016
Horiba Instruments Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are recall — FDA Z-1554-2016
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following…
Class IIFDA: TerminatedHoriba Instruments Inc.
Medical DeviceMay 4, 2016
Becton Dickinson & Co Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II recall — FDA Z-1559-2016
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceMay 4, 2016
Hardy Diagnostics GBS Detect Cat no recall — FDA Z-1571-2016
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product…
Class IIFDA: TerminatedHardy Diagnostics
Medical DeviceMay 4, 2016
Hologic CF InPlex ASR Card recall — FDA Z-1579-2016
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceMay 4, 2016
RESEARCH INSTRUMENTS LTD - SITE B Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150 recall — FDA Z-1584-2016
The units have been fitted with a potentially faulty power supply cable.
Class IIFDA: TerminatedRESEARCH INSTRUMENTS LTD - SITE B
Medical DeviceMay 4, 2016
Corin USA Trinity Acetabular Shell Product Usage: Total Hip Replacement recall — FDA Z-1527-2016
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Class IIFDA: TerminatedCorin USA Limited
Medical DeviceMay 4, 2016
Shimadzu Medical Systems X-Ray Diagnostic Table, Model No recall — FDA Z-1585-2016
Report of unintentional movement of table to reverse tilting.
Class IIFDA: TerminatedShimadzu Medical Systems
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.