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. 2,390 recalls have been distributed to Rhode Island in the last 12 months.

47,970 total recalls
2,390 in last 12 months

Showing 2028120300 of 27,456 recalls

Medical DeviceDecember 22, 2015· Cook Medical Incorporated

Recalled Item: Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Recalled by...

The Issue: Manufacturing of the joint between the inner catheter and stylet of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Acist Medical Systems

Recalled Item: ACIST Medical Systems Recalled by Acist Medical Systems Due to Reports...

The Issue: Reports related to ingress of air into the manifold.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5 Recalled by Ortho-Clinical Diagnostics Due to Increased U90-382 or...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· ConMed Corporation

Recalled Item: Hip Preservation System Signature Series PreBent Burs under the following...

The Issue: Metal shavings released from burs during use are due to contact between the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Therakos Inc

Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...

The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 250 Chemistry Systems Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 4600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Baxter Corporation Englewood

Recalled Item: Baxter Recalled by Baxter Corporation Englewood Due to All lots of RAPIDFILL...

The Issue: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 350 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter Recalled by C.R....

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Recalled by C.R. Bard,...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· GE Medical Systems, LLC

Recalled Item: Mavig Monitor Suspension System Recalled by GE Medical Systems, LLC Due to...

The Issue: GE Healthcare has recently become aware of a reported incident in which a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· EndoChoice, Inc.

Recalled Item: Fuse 1C Colonoscope Recalled by EndoChoice, Inc. Due to The bending section...

The Issue: The bending section of the device may partially separate from the insertion...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· NeoCoil, LLC

Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC...

The Issue: Potential for higher than specified surface temperatures. Use of 3.0T GEM...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Stryker Spine

Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...

The Issue: Reported jamming of the impaction handle when assembled to the Inserter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Elekta, Inc.

Recalled Item: Oncentra External Beam - VMAT - Radiation therapy planning system Recalled...

The Issue: When using the option "Tumor Overlap Fraction" in VMAT planning it has been...

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

Class II — Potential Health HazardOngoing