Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2019
Stryker announces a voluntary field action for certain LIFEPAK 15 units
Corrective action
Stryker announced a voluntary field action for specific LIFEPAK 15 monitor/defibrillator units after oxidation in the Shock button was found to potentially prevent delivery of a defibrillation shock. The company stated that it is contacting customers to arrange correction, including replacement of affected keypads. The announcement concerns only the identified units and describes the action as voluntary.
Company response
Remediation — Stryker
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.
Source excerpt
The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the "Shock" button on the keypad is pressed. This is a result of oxidation that may have formed over time within the "Shock" button.
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
2019
Stryker launches corrective action for LIFEPAK 15 devices
Corrective action
Stryker announced a voluntary field action for specific LIFEPAK 15 monitor/defibrillators after an issue was identified that may prevent a device from delivering a shock when the "Shock" button is pressed. Stryker said it would contact affected customers to arrange correction, including replacement of the affected keypad.
Company response
Remediation — Stryker
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.
Source excerpt
Company Announcement Date: December 27, 2019
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.
2018
Foreign Corrupt Practices Act penalty
The company paid a penalty related to alleged failures to detect and prevent improper-payment risks in sales involving India, China, and Kuwait.
2013
Foreign-corruption settlement
Stryker resolved allegations that improper payments had been made in connection with sales activities in Argentina, Greece, Mexico, Poland, and Romania.
2012
Neptune Waste Management System recall
Several Neptune medical-vacuum models were recalled after a fatal accident and concerns that some devices lacked required FDA clearance.
2012
Rejuvenate and ABG II hip-system controversy
Stryker's Rejuvenate and ABG II hip-replacement systems became subject to FDA action, recall-related consequences, litigation, and penalties after reports that the devices could cause severe pain and other complications.
2008
FDA documentation and biotechnology-facility concerns
The FDA cited quality and compliance problems at a Massachusetts biotechnology facility, including issues involving product documentation. Stryker stated that employees involved in falsifying records had been terminated.
2007
FDA manufacturing and compliance warnings
FDA warning letters identified quality-system, manufacturing, testing, and corrective-action concerns at Stryker facilities in Ireland and New Jersey.