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GE Medical Systems, LLC

GE Medical Systems, LLC Recalls

All product recalls associated with GE Medical Systems, LLC.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

91

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 9061–9080 of 10937 recalls

GE Medical Systems, LLC: GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular I...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

FDAApr 16, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Va...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

FDAApr 16, 2009Nationwide• GE Medical Systems, LLC

Merit Medical Systems, Inc.: 8F Prelude Short Sheath Introducer, 4CM in Length with Ma...

1...452 453454455 456...547

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External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude Short Sheath Introducer, Carolina Kidney and Endo...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 5F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Hitachi Medical Systems America Inc: Hitachi ECLOS Computed Tomography (CT) Scanners, Software...

Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

FDAApr 14, 2009Nationwide• Hitachi Medical Systems America Inc

Merit Medical Systems, Inc.: 6F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography (CT) Scanners, Software ...

Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

FDAApr 14, 2009Nationwide• Hitachi Medical Systems America Inc

Merit Medical Systems, Inc.: 7F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Mindray DS USA, Inc., dba Datascope Patient Monitoring: Panorama Patient Monitoring Network with ambulatory telep...

Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.

FDAApr 10, 2009Nationwide• Mindray DS USA, Inc., dba Datascope Patient Monitoring

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm...

Needles separate from the barrel of the syringes.

FDAApr 9, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Marina Medical Instruments Inc.: VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Cat...

Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.

FDAApr 9, 2009Nationwide• Marina Medical Instruments Inc.

Marina Medical Instruments Inc.: VVD Veronikis Vaginal Dilator - Complete Set Catalog No. ...

Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.

FDAApr 9, 2009Nationwide• Marina Medical Instruments Inc.

Marina Medical Instruments Inc.: VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog...

Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.

FDAApr 9, 2009Nationwide• Marina Medical Instruments Inc.

Polaris Snowmobiles (Polaris) – Fire Risk (2009)

This recall involves model year 2007, 2008 and 2009 Polaris snowmobiles with Clean Fire Injection (CFI) and a left-hand pump flange assembly. The model and serial number identification decal is located on the right side of the tunnel below the seat. The recalled model names and numbers are listed below: MODEL NUMBER Model Year Market Name MODEL NUMBER Model Year Market Name S07PD6HS 2007 600 CLASSIC CFI S08PD6HS 2008 600 CLASSIC CFI S07PP6HS 2007 600 IQ CFI S08PP6HE 2008 INT 600 IQ CFI S07PP6HSA 2007 600 IQ CFI S08PP6HS 2008 600 IQ CFI S07PP6HSB 2007 600 IQ CFI S08PP7JS 2008 700 IQ CFI S07PS6HS 2007 600 SWTCHBK CFI S08PR6HS 2008 600 SWTCHBK CFI S07PS6HSA 2007 600 SWTCHBK CFI S08PR7JS 2008 700 SWTCHBK CFI S07PS6HSB 2007 600 SWTCHBK CFI S08PS6HS 2008 600 SWTCHBK CFI S07PT6HE 2007 INT 600 TRG CFI S08PS7JS 2008 700 SWTCHBK CFI S07PT6HS 2007 600 TRG CFI S08PT6HE 2008 INT 600 TRG CFI S08PB7JE 2008 INT 700 IQ CFI S08PT6HS 2008 600 TRG CFI S08PB7JS 2008 700 IQ CFI S09PT6HE 2009 INT 600 TRG CFI S09PT6HS 2009 600 TRG CFI

CPSCApr 7, 2009Nationwide• Polaris Industries Inc., of Medina, Minn.

Binax, Inc. dba IMPD: Inverness Medical BioStar Strep A OIA MAX, 100 test kit s...

Potential for false positive Strep A results.

FDAApr 6, 2009Nationwide• Binax, Inc. dba IMPD

Evenflo Majestic High Chairs – Safety Issue (2009)

The expanded recall involves Evenflo Majestic™ high chairs, model numbers: 3001395, 3001395A, 3001604, 3001700, 3001713, 3001713A, 3001730A, 3001732, 3001733, 3001742, 3001742A, 3001756, 3001821A, 3001840A, 3001845, 3001848, 3001852, 3001932, 3002719 and 3003845 manufactured between January 23, 2007 and December 31, 2008. The model number and date of manufacture are located on a white label/sticker on the seatback. "Evenflo" is printed on the label and on the front of the tray. Models showing a year of manufacture of 2009 in red ink are not included in the recall.

CPSCApr 2, 2009Nationwide• Evenflo Company Inc., of Miamisburg, Ohio

Evenflo Envision High Chairs – Fall Risk (2009)

The recall involves all Evenflo Envision™ high chairs, including model numbers: 2891321, 2891321A, 2891333, 2891351, 2891351A, 2891365, 2891375, 2891403, 2891403A, 2891466, 2891466A, 2891478, 2891536, 2891536A, 2891573, 2891586, 2892351 and 2892351A. The model number can be found on a white label on the seatback. "Evenflo" and "Envision" are printed on the front of the tray.

CPSCApr 2, 2009Nationwide• Evenflo Company Inc., of Miamisburg, Ohio

Spektrum DX6i Radio Transmitters – Impact Risk (2009)

Laceration Risk

The recalled Spektrum DX6i radio transmitters are used to control model airplanes and helicopters. "Spektrum DX6i" is printed on the front of the transmitters. The transmitters were sold individually or as part of three different ready-to-fly model aircraft. Item numbers and product date codes included in this recall are listed below. The item number is located on the product's packaging. The date code is located on a label inside the transmitter's battery compartment or on the underside of the battery compartment door. Product Item Numbers Date Codes Include: Spektrum DX6i 6-Channel Full Range Radio Transmitter SPM6600 SPM6600E SPM66001E SPMR6600 SPMR6600E SPMR66001 SPMR66001E 807E 808E 809E 810E 811E 812E 901E E-Flite Blade 400 Ready-To-Fly Electric Mini Helicopter EFLH1400 EFLH1400M1 EFLH1400M2 E-Flite T-34 25 ePTS Ready-to- Fly Airplane EFL4800 Hangar 9 P-51 Mustang Mk II PTS Ready-to-Fly Airplane HAN4425

CPSCApr 2, 2009Nationwide• Horizon Hobby Inc., of Champaign, Ill.

Direct Vent Gas Fireplaces (Central Fireplace) – Laceration Risk (2009)

The recall involves Central Fireplace models CF3036MV-LP and CF3036MVB. The model number is located on the data plate behind the control panel door where the gas valve is located.

CPSCMar 27, 2009Nationwide• Central Fireplace, of Greenbush, Minn.