Product Recalls in Rhode Island

Product recalls affecting Rhode Island — including food, drugs, consumer products, medical devices, and vehicles distributed to Rhode Island. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,521 recalls have been distributed to Rhode Island in the last 12 months.

47,970 total recalls
2,521 in last 12 months

Showing 86418660 of 27,456 recalls

Medical DeviceNovember 16, 2021· Roche Molecular Systems, Inc.

Recalled Item: cobas LiatSystem Recalled by Roche Molecular Systems, Inc. Due to Roche has...

The Issue: Roche has identified a small number of cobas Liat analyzer units that have...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Ohio Medical Corporation

Recalled Item: Instavac Portable Suction Pump Recalled by Ohio Medical Corporation Due to...

The Issue: Increase in premature device failures

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Abbott

Recalled Item: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Recalled by Abbott Due to As a...

The Issue: As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

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

Recalled Item: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B...

The Issue: Due to a calculation error in the measurement when using 2D trace (manual...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2...

The Issue: (1)Start-up problem: Intermittently at start-up of the system, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Invacare Corporation

Recalled Item: Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Recalled by...

The Issue: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Invacare Corporation

Recalled Item: Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Recalled by...

The Issue: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Invacare Corporation

Recalled Item: Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with Recalled by...

The Issue: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: BV Endura with Software Release 2.3- A mobile Recalled by Philips North...

The Issue: Instructions for Use do not specify the maximum surface temperature of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: Veradius Unity with Software Release 2.1- Amobile Recalled by Philips North...

The Issue: Instructions for Use do not specify the maximum surface temperature of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: BV Pulsera with Software Release 2.3-A mobile Recalled by Philips North...

The Issue: Instructions for Use do not specify the maximum surface temperature of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2021· Orchestrate Orthodontic Technologies, Inc.

Recalled Item: O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing...

The Issue: Due to product label/labeling being altered from it's approved state.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 10, 2021· Velano Vascular

Recalled Item: PIVO Blood Collection Device 20G Recalled by Velano Vascular Due to...

The Issue: Incomplete sealing of blood collection device unit packages may produce a...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 10, 2021· Tapemark Company

Recalled Item: iontoPATCH On-the-Go Patch Therapy Recalled by Tapemark Company Due to The...

The Issue: The dosage information on the pouch is incorrect; the primary carton label...

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

Class III — Low RiskOngoing
Medical DeviceNovember 10, 2021· Beckman Coulter Inc.

Recalled Item: SYNCHRON Systems Cholesterol (CHOL) Reagent Recalled by Beckman Coulter Inc....

The Issue: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low)...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 9, 2021· Biomerieux Inc

Recalled Item: RAPID 20 E Recalled by Biomerieux Inc Due to There is an error in the new...

The Issue: There is an error in the new version of the package insert. The Reading...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 9, 2021· Coloplast Manufacturing US, LLC

Recalled Item: Torosa Saline-Filled Testicular Prosthesis (Size Small) Recalled by...

The Issue: Product is mislabeled for size.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 9, 2021· Ossur Americas

Recalled Item: Miami J Select Collar Recalled by Ossur Americas Due to Instructions for use...

The Issue: Instructions for use were updated to include additional information to...

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

Class II — Potential Health HazardOngoing