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 94819500 of 29,228 recalls

Medical DeviceJuly 7, 2021· Baxter Healthcare Corporation

Recalled Item: Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recalled by...

The Issue: Software issue: The defect creates a mismatch between linked drug...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit ()- Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Advance Dx, Inc.

Recalled Item: Advance Dx 100 Blood Collection Card Quantity 25 Recalled by Advance Dx,...

The Issue: Due to high glucose test results when using the blood collection cards.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2021· Zeltiq Aesthetics, Inc

Recalled Item: CoolSculpting Elite System The CoolSculpting System SW release 2.0 Recalled...

The Issue: An incorrect error messaging system that could potentially lead to: 1)...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 2, 2021· Hero Health

Recalled Item: The Hero Model 100 (H-100) is a system consisting of Recalled by Hero Health...

The Issue: Due to dispenser prompting for a missed dose that had already been dispensed

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Howmedica Osteonics Corp.

Recalled Item: Triathlon Prim CEM FXD BPLT 7 Recalled by Howmedica Osteonics Corp. Due to...

The Issue: The internal profile of the Triathlon Prim (Baseplate) is potentially...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Arthroscopy Kit Recalled by Medline Industries Inc Due to The kits...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 ANTIGEN QC Recalled by Beckman Coulter Inc. Due to...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION Recalled by Beckman Coulter...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Knee Arthroscopy Kit Recalled by Medline Industries Inc Due to The...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 Antigen Recalled by Beckman Coulter Inc. Due to SARS-CoV-2...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Total Knee Recalled by Medline Industries Inc Due to The kits may...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Shoulder CDS convenience kits Recalled by Medline Industries Inc Due...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: Access SARS-CoV-2 Antigen Calibrators Recalled by Beckman Coulter Inc. Due...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Verathon, Inc.

Recalled Item: GlideScope Go Monitors Recalled by Verathon, Inc. Due to Handheld video...

The Issue: Handheld video monitor failed to meet the labeled IP67 rating which may...

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

Class III — Low RiskOngoing
Medical DeviceJune 30, 2021· GE Healthcare, LLC

Recalled Item: Revolution Apex Recalled by GE Healthcare, LLC Due to The accumulated dose...

The Issue: The accumulated dose is incorrectly displayed in certain situations. There...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 30, 2021· GE Healthcare, LLC

Recalled Item: Revolution CT Recalled by GE Healthcare, LLC Due to The accumulated dose is...

The Issue: The accumulated dose is incorrectly displayed in certain situations. There...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 30, 2021· GE Healthcare, LLC

Recalled Item: Computed Tomography Systems Revolution CT Recalled by GE Healthcare, LLC Due...

The Issue: The accumulated dose is incorrectly displayed in certain situations....

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

Class II — Potential Health HazardOngoing