Product Recalls in Indiana

Product recalls affecting Indiana — including food, drugs, consumer products, medical devices, and vehicles distributed to Indiana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,725 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,725 in last 12 months

Showing 94619480 of 29,228 recalls

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
Medical DeviceJuly 8, 2021· Carl Zeiss Meditec, Inc.

Recalled Item: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX Recalled...

The Issue: Due to failure to acquire pre-market clearance for its high resolution...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing