Product Recalls in Pennsylvania

Product recalls affecting Pennsylvania — including food, drugs, consumer products, medical devices, and vehicles distributed to Pennsylvania. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,679 recalls have been distributed to Pennsylvania in the last 12 months.

55,602 total recalls
2,679 in last 12 months

Showing 2602126040 of 29,947 recalls

Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS AST For the In vitro quantitative determination of AST Recalled by AMS...

The Issue: Marketing the devices outside 510(k) requirements

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS URIC ACID For the In vitro quantitative determination of Recalled by AMS...

The Issue: Marketing the devices outside 510(k) requirements

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Philips Medical Systems (Cleveland), Inc.

Recalled Item: Pinnacle3 Radiation Therapy Planning (RTP) System Recalled by Philips...

The Issue: Philips Medical Systems have recently determined that a software...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS BUN UREA NITROGEN For the In vitro quantitative determination Recalled...

The Issue: Marketing the devices outside 510(k) requirements

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Phillips Respironics, Inc.

Recalled Item: Trilogy Ventilators The Respironics Trilogy 100 system provides continuous...

The Issue: Internal testing revealed a potentially defective component on the power...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 11, 2014· Synthes, Inc.

Recalled Item: The Synthes Hohmann Retractor Recalled by Synthes, Inc. Due to The Synthes...

The Issue: The Synthes Hohmann Retractor was mis-etched on the product and package as...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 10, 2014· Biomerieux Inc

Recalled Item: bioMerieux PREVI Isola System (General purpose Recalled by Biomerieux Inc...

The Issue: The firm has determined the product may fail to dispense the sample to the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 10, 2014· Heraeus Kulzer, LLC.

Recalled Item: BencoDental tartar & stain remover ultrasonic cleaning solution Product...

The Issue: As the result of a complaint to Heraeus Kulzer's customer service...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 10, 2014· Thermedx LLC

Recalled Item: The Thermedx Fluid Management System is designed to provide irrigation...

The Issue: A vendor changed the manufacturing process of a component used in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Draeger Medical Systems, Inc.

Recalled Item: Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Recalled by...

The Issue: The battery capacity of the optional PS500 Power Supply Unit of the Infinity...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: Elscint APEX Helix Recalled by GE Healthcare, LLC Due to Potential safety...

The Issue: Potential safety issue related to unintended radial detector motion, which...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Baxter Healthcare Corp.

Recalled Item: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product...

The Issue: Baxter Healthcare Corporation has issued an Urgent Device Correction for the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 7, 2014· Djo Surgical

Recalled Item: FMP X-alt Acetabular Liner This acetabular liner is intended for Recalled by...

The Issue: Packaging error -- two different types and sizes of acetabular liners used...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Leica Biosystems Imaging, Inc.

Recalled Item: HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Recalled by...

The Issue: In an abundance of caution, Aperio (now known as Lecia Biosystems) is...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: AXIOM Artis Systems Product usage: Artis zee is a family Recalled by Siemens...

The Issue: Certain units of the AXIOM Artis Systems are using a flat detector cooling...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The Recalled...

The Issue: Potential safety issue related to unintended radial detector motion, which...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For...

The Issue: Potential safety issue related to unintended radial detector motion, which...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Zee Angiographic x-ray systems. Recalled by Siemens Medical Solutions...

The Issue: An inappropriate cable connection was assembled for certain Artis zee...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Pega Medical Inc.

Recalled Item: Pega Medical Inc. Recalled by Pega Medical Inc. Due to The Male Components...

The Issue: The Male Components in this lot are made of material with lower strength...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 6, 2014· Medtronic Vascular

Recalled Item: Medtronic Everest 20cc Inflation Device Recalled by Medtronic Vascular Due...

The Issue: Incorrect master label.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing