Product Recalls in Hawaii

Product recalls affecting Hawaii — including food, drugs, consumer products, medical devices, and vehicles distributed to Hawaii. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,412 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,412 in last 12 months

Showing 2100121020 of 27,645 recalls

Medical DeviceOctober 13, 2015· Event Medical LTD

Recalled Item: Inspiration Ventilator System Recalled by Event Medical LTD Due to A...

The Issue: A component on the systems power board can fail in a manner which can cause...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 13, 2015· Stryker Medical Division of Stryker Corporation

Recalled Item: Two-stage and three-stage I.V. poles are shipped as an optional Recalled by...

The Issue: It was identified by a customer complaint that some I.V. poles were...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 13, 2015· Beckman Coulter Inc.

Recalled Item: Access CEA Assay Recalled by Beckman Coulter Inc. Due to Beckman Coulter is...

The Issue: Beckman Coulter is recalling the Access CEA reagent packs because they were...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2015· Miramar Labs, Inc.

Recalled Item: miraDry System consisting of the MD4000-MC Console Recalled by Miramar Labs,...

The Issue: Update to labeling for the miraDry Console to remind users to only use...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2015· CareFusion 303, Inc.

Recalled Item: SmartSite Extension Set Recalled by CareFusion 303, Inc. Due to CareFusion...

The Issue: CareFusion is recalling the SmartSite Extension Set due to disconnection and...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2015· Synthes (USA) Products LLC

Recalled Item: Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold Recalled by...

The Issue: The affected part number and lot listed above is incorrectly etched with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2015· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry XPT Systems Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2015· Ivoclar A. G.

Recalled Item: Helioseal F Sealant 1 x 1.25 g Recalled by Ivoclar A. G. Due to A defect...

The Issue: A defect occurred in the production process of Helioseal F Sealant; the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2015· Cook Inc.

Recalled Item: Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in...

The Issue: Reports of catheter tip splits and or separation. Loss of device function,...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 7, 2015· Hill-Rom, Inc.

Recalled Item: Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed Recalled by...

The Issue: Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2015· C.R. Bard, Inc.

Recalled Item: Antibacterial Hydro Personal Catheter Recalled by C.R. Bard, Inc. Due to...

The Issue: Incorrect unit labeling. The case label and shelf box are correct, Product...

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

Class III — Low RiskOngoing
Medical DeviceOctober 2, 2015· Welch Allyn Inc

Recalled Item: Welch Allyn KleenSpec Corded Illumination System Recalled by Welch Allyn Inc...

The Issue: The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2015· Philips Electronics North America Corporation

Recalled Item: Philips X-Ray Systems Recalled by Philips Electronics North America...

The Issue: Upon initiating Fluoroscopy the user may encounter a user message Fluoro...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2015· Powers Medical Devices, LLC

Recalled Item: The "Pacifier Activated Lullaby" (PAL) System composed of three major...

The Issue: PAL unit has undergone significant technological changes since the previous...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2015· Merge Healthcare, Inc.

Recalled Item: Merge Cardio software. Merge Cardio is a system intended to Recalled by...

The Issue: Reporting feature times out after inactivity for more than an hour sending...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2015· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD CD3 (SK7) FITC Recalled by Becton, Dickinson and Company, BD Biosciences...

The Issue: Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

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

Class III — Low RiskOngoing
Medical DeviceSeptember 30, 2015· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista System (MG) Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: Erroneous low results on a small number of reagent wells. There is the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2015· O-Two Medical Technologies, Inc.

Recalled Item: Burn Relief¿ Recalled by O-Two Medical Technologies, Inc. Due to For lack of...

The Issue: For lack of evidence to validate effectiveness of sterilization dose, O-Two...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Recalled by Stryker Howmedica Osteonics Corp. Due to...

The Issue: Stryker is recalling various lots of the Trithion MIS Modular Distal Capture...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 28, 2015· GE Healthcare

Recalled Item: The Centricity Universal Viewer Version is a device that displays Recalled...

The Issue: Inaccurate distance measurements with magnified projection X-ray images.

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

Class II — Potential Health HazardOngoing