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American Medical Systems

American Medical Systems Recalls

All product recalls associated with American Medical Systems.

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Recall Summary

Total Recalls

1000

Past Year

583

Class I (Serious)

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 9841–9860 of 10937 recalls

American Medical Systems: AMS 700 Ultrex Preconnected penile Prosthesis with Inhibi...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

American Medical Systems: AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, pro...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

GE OEC Medical Systems, Inc: OEC 9800 Plus Fluoroscopic X-ray System,

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

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American Medical Systems: AMS 700 CX Preconnected penile Prosthesis with InhibiZone...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

GE OEC Medical Systems, Inc: OEC 9800 Fluoroscopic X-ray System, Model Number A349855,...

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

American Medical Systems: AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis wit...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

Curling Irons (Conair) – shock hazard (2007)

Laceration Risk

This recall involves ceramic, gold-matte finish curling irons. The irons have a 1, 1¼, or 1½-inch barrel, metal counter rest, vertically placed ON-OFF buttons, and a heat set dial that ranges from 0 to 30. A four-digit date code can be found on the plug prong. Date codes included in this recall range from November 2005 through July 2006 (ex. 0706). The name "Conair" is printed on the handle of the iron.

CPSCFeb 7, 2007Nationwide• Conair Corp., of Stamford, Conn.

General Electric Med Systems LLC: GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging...

Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely.

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic ...

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic I...

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

Medtronic Inc. Cardiac Rhythm Managment: Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive...

Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

FDAFeb 5, 2007AL, AZ, AR +19 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Vitatron T-Series Dual Chamber pacemaker T60 DR, model T6...

Pacing rate: Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

FDAFeb 5, 2007AL, AZ, AR +19 more• Medtronic Inc. Cardiac Rhythm Managment

Smiths Medical MD, Inc.: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medi...

Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

FDAFeb 3, 2007Nationwide• Smiths Medical MD, Inc.

Toshiba American Med Sys Inc: Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with...

When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.

FDAFeb 2, 2007Nationwide• Toshiba American Med Sys Inc

Toshiba American Med Sys Inc: Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with...

FDAFeb 2, 2007Nationwide• Toshiba American Med Sys Inc

Medtronic Sofamor Danek USA Inc: Colorado 2 Spinal System, Anterior Plate, REF8639500, for...

Bone screws may pull though the plate.

FDAFeb 2, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom: VITROS Immunodiagnostics Products HBsAg Reagent Pack, Ca...

Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.

FDAFeb 1, 2007PR• Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom

Becton Dickinson & Company: BD Integra 1ml Insulin Syringe with Retracting Precision ...

The needle becomes detached from the hub/syringe

FDAJan 27, 2007Nationwide• Becton Dickinson & Company

General Electric Medical Systems Information Technology: GE Healthcare CIC Pro Clinical Information Center, Centra...

Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.

FDAJan 24, 2007DE, HI, ID +6 more• General Electric Medical Systems Information Technology

General Electric Medical Systems Information Technology: GE Healthcare CIC Pro Clinical Information Center, Centra...

Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .

FDAJan 24, 2007Nationwide• General Electric Medical Systems Information Technology