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. 2,857 recalls have been distributed to Pennsylvania in the last 12 months.

55,602 total recalls
2,857 in last 12 months

Showing 89819000 of 29,947 recalls

Medical DeviceNovember 19, 2021· DiaSorin Molecular LLC

Recalled Item: Simplexa Direct Amplification Disc Kit Recalled by DiaSorin Molecular LLC...

The Issue: A subset of affected discs are at risk of leakage when it is used more than...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Philips North America Llc

Recalled Item: Philips Allura Xper FD series with Software Version Number: 2.1.x- Recalled...

The Issue: Set screws securing the two gliding rods of the Extra Monitors (called 7th...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2021· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An...

The Issue: (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Luminex Corporation

Recalled Item: ARIES HSV 1&2 Assay Recalled by Luminex Corporation Due to Impacted lot may...

The Issue: Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core SMILE Pack 1-Medical Kit intended to be Recalled by Beaver...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core LASIK Pack 2-Medical Kit- intended to be Recalled by Beaver...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Stanley Security Solutions Inc

Recalled Item: Senior Living Arial Emergency and Nurse Call Systems Recalled by Stanley...

The Issue: Systems are not alarming due to increased memory consumption.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be Recalled by...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core Phaco Pack 2- Medical Kit intended to Recalled by Beaver Visitec...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Kit intended Recalled by...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Beaver Visitec International, Inc.

Recalled Item: Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to Recalled...

The Issue: Kit packaging may have small holes compromising product sterility

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Roche Molecular Systems, Inc.

Recalled Item: cobas LiatSystem Recalled by Roche Molecular Systems, Inc. Due to Roche has...

The Issue: Roche has identified a small number of cobas Liat analyzer units that have...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Ohio Medical Corporation

Recalled Item: Instavac Portable Suction Pump Recalled by Ohio Medical Corporation Due to...

The Issue: Increase in premature device failures

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Abbott

Recalled Item: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Recalled by Abbott Due to As a...

The Issue: As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 12, 2021· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B...

The Issue: Due to a calculation error in the measurement when using 2D trace (manual...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2...

The Issue: (1)Start-up problem: Intermittently at start-up of the system, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Invacare Corporation

Recalled Item: Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Recalled by...

The Issue: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Invacare Corporation

Recalled Item: Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Recalled by...

The Issue: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2...

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

Class II — Potential Health HazardOngoing