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. 2,604 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,604 in last 12 months

Showing 1812118140 of 53,528 recalls

Medical DeviceSeptember 24, 2020· Zimmer Biomet, Inc.

Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene Recalled by...

The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Zimmer Biomet, Inc.

Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene Recalled by...

The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Zimmer Biomet, Inc.

Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene Recalled by...

The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Zimmer Biomet, Inc.

Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene Recalled by...

The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Zimmer Biomet, Inc.

Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene Recalled by...

The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: Streamline TL Navigation System Recalled by RTI Surgical, Inc. (dba Pioneer...

The Issue: The Streamline Navigation System taps have experienced binding with other...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: Streamline MIS Navigation System Taps Recalled by RTI Surgical, Inc. (dba...

The Issue: The Streamline Navigation System taps have experienced binding with other...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Yuno Mobile Operating Table - Product Usage: Intended for support Recalled...

The Issue: Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 24, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Yuno II Mobile Operating Table - Product Usage: support and Recalled by...

The Issue: Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and...

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

Class II — Potential Health HazardOngoing
DrugSeptember 23, 2020· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: RIOMET ER (metformin hydrochloride for extended-release oral suspension)...

The Issue: CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 22, 2020· Flexicare Medical Ltd.

Recalled Item: ProVu Single Use Video Stylet with ET Tube Recalled by Flexicare Medical...

The Issue: When the video stylet cuff is over-inflated there is potential for occlusion...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 22, 2020· Cardinal Health 200, LLC

Recalled Item: Kangaroo Connect 1000ml Bag Set Recalled by Cardinal Health 200, LLC Due to...

The Issue: The feeding spike sets may leak at the interface of the tube and spike...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Cardinal Health 200, LLC

Recalled Item: Kangaroo Connect 500ml Bag Set Recalled by Cardinal Health 200, LLC Due to...

The Issue: The feeding spike sets may leak at the interface of the tube and spike...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Gordian Surgical

Recalled Item: TroClose 1200 - Product Usage: intended for use in a variety of gynecologic...

The Issue: Endotoxin test results found above the acceptable levels in LAL test (above...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Pentax of America Inc

Recalled Item: 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal) Recalled by Pentax...

The Issue: There is an intermittent software issue that could affect the systems, in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Boston Scientific Corporation

Recalled Item: Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI...

The Issue: Incorrectly installed base.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Pentax of America Inc

Recalled Item: 9310HD Digital Video Capture Module with software version 3.4.0 or Recalled...

The Issue: There is an intermittent software issue that could affect the systems, in...

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

Class II — Potential Health HazardOngoing
FoodSeptember 21, 2020· Wismettac Asian Foods, INC

Recalled Item: Shirakiku brand Black Fungus (Kikurage) Recalled by Wismettac Asian Foods,...

The Issue: California Department of Public Health sampled and tested Shirakiku brand...

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceSeptember 21, 2020· Stereotaxis Inc

Recalled Item: Niobe ES System Recalled by Stereotaxis Inc Due to There is a potential for...

The Issue: There is a potential for fire in the inside computer cabinet.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2020· Smith & Nephew, Inc.

Recalled Item: 5.5MM Arthrogarde Hip Access Cannula Recalled by Smith & Nephew, Inc. Due to...

The Issue: The J Lock feature on the cannula body was manufactured incorrectly,...

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

Class II — Potential Health HazardOngoing