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. 2,691 recalls have been distributed to Pennsylvania in the last 12 months.

55,602 total recalls
2,691 in last 12 months

Showing 2458124600 of 29,947 recalls

Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: Non-sterile drape Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: LUNA Chest Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Pulsion Medical Inc

Recalled Item: Pulsiocath PiCCO ProAQT Monitoring Kit Recalled by Pulsion Medical Inc Due...

The Issue: Internal testing and investigation of the packaging revealed cracks and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Medtronic MiniMed Inc.

Recalled Item: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets Recalled by...

The Issue: Tubing may detach at the connect/disconnect location on the MiniMed...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Bausch & Lomb Inc

Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris Recalled by...

The Issue: A software anomaly was identified where the system may automatically...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Bausch & Lomb Inc

Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris Recalled by...

The Issue: A software anomaly was identified where the system may automatically...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2014· Elekta, Inc.

Recalled Item: MOSAIQ Product Usage: MOSAIQ is an oncology information system used Recalled...

The Issue: A problem can exist in MOSAIQ resulting in the display of incorrect numeric...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 31, 2014· Accuray Incorporated

Recalled Item: CyberKnife Robotic Radiosurgery System with the first generation IRIS...

The Issue: Software upgrade to correct potential safety issue related to CyberKnife...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2014· Alcon Research, Ltd.

Recalled Item: INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system....

The Issue: Alcon is conducting a medical device recall due to the possible presence of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2014· Respironics California Inc

Recalled Item: Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit...

The Issue: If the power supply fan mounting screws are installed incorrectly, the ends...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2014· Radiometer America Inc

Recalled Item: Crea A and B membranes Recalled by Radiometer America Inc Due to Negative...

The Issue: Negative drift on QC during in-use lifetime of CREA membranes can be observed.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2014· Remel Inc

Recalled Item: Remel TB Potassium Permanganate (.5% Aqueous) 40192 Recalled by Remel Inc...

The Issue: The product may appear cloudy or discolored and may not perform correctly in...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2014· Summit Industries Inc.

Recalled Item: The J700 Floor Mounted Tube Stand (FMTS) is intended to Recalled by Summit...

The Issue: The welds on J700 tube stands may be insufficient resulting in tube stand...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2014· Cooper Vision Caribbean Corp.

Recalled Item: Soft Contact Lens Recalled by Cooper Vision Caribbean Corp. Due to Portions...

The Issue: Portions of the lots may contain units with an incorrect lens axis condition.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: Mammomat Inspiration system: Product Usage: mammography exams Recalled by...

The Issue: It was determined that if the Mammomat Inspiration system is not secured to...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2014· CooperSurgical, Inc.

Recalled Item: CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D Recalled by...

The Issue: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2014· Straumann USA, LLC

Recalled Item: Drill set long Recalled by Straumann USA, LLC Due to Drill set may contain...

The Issue: Drill set may contain incorrect drill.

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

Class II — Potential Health HazardOngoing