Medical DeviceJul 8, 2015
Covidien Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item recall — FDA Z-1881-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1182
29,963 detailed records are currently available in this category.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x recall — FDA Z-1911-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
GE Healthcare Innova IGS 630 recall — FDA Z-1984-2015
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova,…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 8, 2015
Vascutek Gelseal Straight Diameter 8mm Length 15cm recall — FDA Z-1912-2015
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Class IIFDA: TerminatedVascutek, Ltd.
Medical DeviceJul 8, 2015
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in recall — FDA Z-1917-2015
Complaints with the HVAD Abnormal Power Source Switching.
Class IIFDA: OngoingHeartWare Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item recall — FDA Z-1900-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Abbott Laboratories ICT Serum Calibrator REF 146-03 recall — FDA Z-1932-2015
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
Class IIFDA: TerminatedAbbott Laboratories
Medical DeviceJul 8, 2015
GE Healthcare Innova IGS 620 recall — FDA Z-1983-2015
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova,…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x recall — FDA Z-1909-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740 recall — FDA Z-1975-2015
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova,…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code recall — FDA Z-1890-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Varian Medical Systems The VariSource iX series afterloader systems are computer controlled recall — FDA Z-1849-2015
After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects…
Class IIFDA: TerminatedVarian Medical Systems Inc.
Medical DeviceJul 8, 2015
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179 recall — FDA Z-1965-2015
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust…
Class IIFDA: TerminatedHamilton Medical, Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item recall — FDA Z-1899-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Siemens Healthcare Diagnostics The Rapidlab 1260 system is a blood gas analyzer used for recall — FDA Z-1961-2015
D50 and D51 Diagnostic error codes are not functional.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceJul 8, 2015
GE Healthcare Innova 3100IQ recall — FDA Z-1978-2015
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova,…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 8, 2015
Covidien Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item recall — FDA Z-1874-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P recall — FDA Z-1876-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar recall — FDA Z-1960-2015
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
Class IIFDA: TerminatedSpine Wave, Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item recall — FDA Z-1905-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Roche Diagnostics Operations LDL-Cholesterol gen.2 recall — FDA Z-1927-2015
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item recall — FDA Z-1893-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
New Star Lasers StoneLight 30 Laser System (NS3000) recall — FDA Z-1918-2015
During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered…
Class IIFDA: TerminatedNew Star Lasers, Inc.
Medical DeviceJul 8, 2015
Roche Diagnostics Operations Cholesterol CHOD-PAP recall — FDA Z-1920-2015
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples…
Class IIFDA: TerminatedRoche Diagnostics Operations, 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.