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Stryker Instruments Div. of Stryker Corporation

Stryker Instruments Div. of Stryker Corporation Recalls

All product recalls associated with Stryker Instruments Div. of Stryker Corporation.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

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 31781–31800 of 37665 recalls

PainPump ExFen 10in Catheter (Stryker) - Potential Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

PainPump 270mL Two-Site Kit (Stryker) - Potential Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

PainPump2 Standard Catheter (Stryker) - Potential Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

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FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

PainPump2 ExFen 5 Catheter (Stryker) - Potential Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

PainPump2 10.0 Catheter (Stryker) - Potential Catheter Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

PainPump2 400mL Two-Site Kit (Stryker) - Potential Failure (2009)

The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

FDAJun 16, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

VARIANT II Hemoglobin A1c Program (Bio-Rad) - Calibration Failure (2009)

Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

FDAJun 15, 2009Nationwide• Bio-Rad Laboratories Inc

Epicor UltraWand (St. Jude Medical) - Tissue Overheating (2009)

The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has

FDAJun 15, 2009AL, AZ, CA +33 more• St. Jude Medical Atrial Fibrillation Division Inc

Focal Radiation Planning System (CMS) - Coordinate Error (2009)

Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

FDAJun 12, 2009Nationwide• Computerized Medical Systems Inc

Toaster Ovens (Wolfgang Puck) – electrical issue (2009)

The recalled toasters have model #WPTOT010 with date codes 3608, 3908, 0407, 0607, or 0807 or model # BTOT0010 with date code 0207. The model numbers and date codes are located on an Underwriters Laboratories (UL) label, which is affixed to the back of the unit. The black and stainless steel toasters have "Wolfgang Puck" or "Wolfgang Puck Bistro Collection" stamped on the lower front right corner. They feature a stainless steel handle on the oven door, three black knobs for controlling cooking, and a black push-down lever for toasting. Two slots for toasting bread and similar products are located on the top of the toaster.

CPSCJun 12, 2009Nationwide• Kingpower Electrical Appliances of China

Alaris Pump Module (Cardinal Health) - Infusion Risk (2009)

There is a potential risk of over infusion when certain fluids solidify in the pumping mechanism of the Alaris Pump module. This notification is to reinforce the importance of proper techniques for IV set loading and cleaning. When IV sets are improperly loaded, the set can tear and cause medication to leak and potentially enter the bezel area. Improper cleaning of the device, such as using hig

FDAJun 12, 2009PR• Cardinal Health 303 dba Cardinal Health

Alaris PC Unit (Cardinal Health) - Medication Delivery Risk (2009)

There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, an

FDAJun 12, 2009PR• Cardinal Health 303 dba Cardinal Health

Alaris PC Unit (Cardinal Health) - Electrical Discharge Issue (2009)

There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these units there is a potential for the keypad not being responsive, key entries without key presses, or key entries that register incorrectly which may result in an over-infusion or under-infusion. An over

FDAJun 12, 2009PR• Cardinal Health 303 dba Cardinal Health

Alaris PC Unit (Cardinal Health) - Medication Delivery Risk (2009)

Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed

FDAJun 12, 2009PR• Cardinal Health 303 dba Cardinal Health

Alaris IUI Connectors (Cardinal Health) - Connector Failure (2009)

There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

FDAJun 12, 2009PR• Cardinal Health 303 dba Cardinal Health

Carendo Hygiene Chair (ArjoHuntleigh) - Pinching Risk (2009)

Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.

FDAJun 11, 2009Nationwide• ArjoHuntleigh

FreeStyle Lite Test Strips (Abbott) - Low Result Potential (2009)

Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.

FDAJun 10, 2009AL, AZ, CA +14 more• Abbott Diabetes Care, Inc.

NDI P7 Position Sensor (Zimmer CAS) - Retrospective Recall (2009)

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

FDAJun 9, 2009FL, IN, KS +5 more• Orthosoft, Inc. dba Zimmer CAS

NDI P7 Position Sensor (Zimmer CAS) - Retrospective Recall (2009)

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

Class IIModerate

FDAJun 9, 2009FL, IN, KS +5 more• Orthosoft, Inc. dba Zimmer CAS

Trident Acetabular System (Stryker) - Surgical Protocol Update (2009)

The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

FDAJun 9, 2009Nationwide• Stryker Howmedica Osteonics Corp.