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. 2,391 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,391 in last 12 months

Showing 2238122400 of 27,645 recalls

Medical DeviceJanuary 2, 2015· Arrow International Inc

Recalled Item: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The...

The Issue: Foreign material found within the kits. The foreign material, white or black...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Clinical Innovations, LLC

Recalled Item: Ebb Complete Tamponade System Recalled by Clinical Innovations, LLC Due to...

The Issue: Potential for a balloon leak in all lots of (CTS-1000) manufactured since...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1265 System Recalled by Siemens Healthcare Diagnostics Inc Due to...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1245 System Recalled by Siemens Healthcare Diagnostics Inc Due to...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint 405 Blood Gas Analyzer Recalled by Siemens Healthcare Diagnostics...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint 500 Blood Gas Analyzer Recalled by Siemens Healthcare Diagnostics...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Hand-held Barcode Scanner Recalled by Ortho-Clinical Diagnostics Due...

The Issue: In combination with the Batch Programming option (only) for programming...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Baxter Corporation Englewood

Recalled Item: Baxter Recalled by Baxter Corporation Englewood Due to Self-Righting Luer...

The Issue: Self-Righting Luer Tip Caps were manufactured and shipped with a missing...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Dick's Sporting Goods

Recalled Item: Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG) Recalled...

The Issue: Reports of customers falling from the Inversion Table and sustaining...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Cardinal Health

Recalled Item: Lubricated Intubating Stylet 6FR that is inserted into an endotracheal...

The Issue: A small piece of the stylet sheath has the potential to shear off upon...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: FAR-Infrared Heat Home Sauna Recalled by Therasage, LLC. Due to Product...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: Portable FAR Infrared Sauna Indications including Recalled by Therasage,...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Philips Medical Systems, Inc.

Recalled Item: HeartStart MRx monitor/defibrillator Models M3535A Recalled by Philips...

The Issue: MRx monitor/defibrillator could reboot at an indeterminate time, potentially...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: FAR-Infrared Heat Home Sauna Recalled by Therasage, LLC. Due to Product...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2014· Cordis Corporation

Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses...

The Issue: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Flyte Togas are components of the Stryker Flyte System and Recalled by...

The Issue: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number...

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

Class III — Low RiskOngoing
Medical DeviceDecember 19, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: LINAC Accelerators: ARTISTE Recalled by Siemens Medical Solutions USA, Inc...

The Issue: A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· BD Biosciences, Systems & Reagents

Recalled Item: Anti-Lambda APC-H7 Recalled by BD Biosciences, Systems & Reagents Due to Two...

The Issue: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Sunrise Medical (US) LLC

Recalled Item: Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. Recalled by Sunrise...

The Issue: There is the potential for the height adjustable handle to dislodge due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Fresenius Kabi USA, LLC

Recalled Item: HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION Recalled by Fresenius Kabi USA, LLC...

The Issue: The lot failed pH specification.

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

Class II — Potential Health HazardOngoing