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. 2,547 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,547 in last 12 months

Showing 2544125460 of 53,528 recalls

Medical DeviceAugust 31, 2018· GE Healthcare, LLC

Recalled Item: Solar 8000i Patient Monitoring System is used to monitor physiologic...

The Issue: The patient monitors may simultaneously restart as designed if all are...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2018· GE Healthcare, LLC

Recalled Item: Dash 3000 Patient Monitoring System is used to monitor physiologic Recalled...

The Issue: The patient monitors may simultaneously restart as designed if all are...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2018· GE Healthcare, LLC

Recalled Item: Solar 8000M Patient Monitoring System is used to monitor physiologic...

The Issue: The patient monitors may simultaneously restart as designed if all are...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2018· GE Healthcare, LLC

Recalled Item: Solar 9500 Information Monitoring System is used to monitor physiologic...

The Issue: The patient monitors may simultaneously restart as designed if all are...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2018· Accuray Incorporated

Recalled Item: Ashland(TM) Box Film Ball Cube II EBT3 Recalled by Accuray Incorporated Due...

The Issue: the Ball Cube II phantom calibration film was not manufactured within...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: Mitek Screw and Washer Depth Gauge Recalled by DePuy Mitek, Inc., a Johnson...

The Issue: The device has an offset in the design that results in a reading...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm 1000 2nd Edition Imaging System Recalled by Medtronic Navigation,...

The Issue: Software anomalies were reported to affect the following system...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2018· Arrow International Inc

Recalled Item: Arrow AGB + Multi-Lumen CVC Kit Recalled by Arrow International Inc Due to...

The Issue: The product was shipped after its expiry date due to a system error. The...

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

Class II — Potential Health HazardOngoing
FoodAugust 29, 2018· Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc.

Recalled Item: CedarLane Organic Salads Recalled by Cedarlane Natural Foods Inc/Frankly...

The Issue: Discovery that the product is labeled as gluten free but contains wheat...

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceAugust 28, 2018· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo 220/240V AC Recalled by Terumo Cardiovascular Systems Corporation Due...

The Issue: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2018· Alcon Research, LTD.

Recalled Item: CyPass System 241-S Recalled by Alcon Research, LTD. Due to Analysis of the...

The Issue: Analysis of the completed dataset from the COMPASS-XT long-term study showed...

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

Class I — Serious Health HazardOngoing