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. 2,838 recalls have been distributed to Pennsylvania in the last 12 months.

55,602 total recalls
2,838 in last 12 months

Showing 95819600 of 29,947 recalls

Medical DeviceJuly 13, 2021· Micro Therapeutics Inc,

Recalled Item: Pipeline Flex Embolization Device Recalled by Micro Therapeutics Inc, Due to...

The Issue: Due to potential push wire fractures in the delivery system during use. The...

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

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

Recalled Item: ACUSON Juniper Diagnostic Ultrasound System Recalled by Siemens Medical...

The Issue: Due to intermittent failures of the power supply in the ultrasound system...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· W. L. Gore & Associates Inc.

Recalled Item: Gore Molding & Occlusion Balloon Catheter Recalled by W. L. Gore &...

The Issue: Complaints received concerning Balloon Catheter leakage from the guidewire...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Abbott Laboratories, Inc

Recalled Item: Alinity s System . An automated immunoassay analyzer for Recalled by Abbott...

The Issue: A design defect (hardware and software) allows liquid waste pressure to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent....

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Recalled...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Recalled by...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 9, 2021· Copan Italia

Recalled Item: COPAN FLOQSwabs Recalled by Copan Italia Due to A sterility assurance level...

The Issue: A sterility assurance level of 10-6 cannot be guaranteed due to intentional...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· PROCEPT BIOROBOTICS CORPORATION

Recalled Item: AQUABEAM Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to Scope...

The Issue: Scope tube tip may detach from the telescoping tube, which is attached to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: CIRCUL8 LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to CIRCUL8...

The Issue: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: EVEXIA LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to EVEXIA...

The Issue: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Argon Medical Devices, Inc

Recalled Item: Scorpion Portal Vein Access Set - Product Usage: used to Recalled by Argon...

The Issue: As a result of design changes, sheaths have exhibited cracking/breaking at...

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

Class II — Potential Health HazardOngoing