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 2276122780 of 27,645 recalls

Medical DeviceNovember 6, 2014· ConMed Corporation

Recalled Item: ADULT Radiotransparent Electrode Recalled by ConMed Corporation Due to...

The Issue: Philips Healthcare made changes to the design of the connection between...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 6, 2014· ConMed Corporation

Recalled Item: CONMED ADULT R2 Multifunction Electrodes Recalled by ConMed Corporation Due...

The Issue: Philips Healthcare made changes to the design of the connection between...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 6, 2014· Fisher & Paykel Healthcare, Ltd.

Recalled Item: Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and...

The Issue: Breakage of the nut that secures the heater head in place, which can cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 6, 2014· Synthes (USA) Products LLC

Recalled Item: Synthes Small Electric Drive (SED) Recalled by Synthes (USA) Products LLC...

The Issue: The device may operate solely in reverse mode, not operate in reverse mode...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 6, 2014· Abbott Medical Optics Inc (AMO)

Recalled Item: Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate...

The Issue: AMO has received complaints where the finger grip dislodged while depressing...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Toshiba American Medical Systems Inc

Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A...

The Issue: Potential problem with the cardiac function analysis software (CFA)....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Gambro Renal Products Inc

Recalled Item: Polyflux Revaclear Dialyzer Recalled by Gambro Renal Products Inc Due to...

The Issue: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Gambro Renal Products Inc

Recalled Item: Polyflux Revaclear Max Dialyzer Recalled by Gambro Renal Products Inc Due to...

The Issue: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Toshiba American Medical Systems Inc

Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A...

The Issue: Potential problem with the cardiac function analysis software (CFA)....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Bausch & Lomb Inc

Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris Recalled by...

The Issue: A software anomaly was identified where the system may automatically...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Medtronic MiniMed Inc.

Recalled Item: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets Recalled by...

The Issue: Tubing may detach at the connect/disconnect location on the MiniMed...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Bausch & Lomb Inc

Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Recalled by Bausch & Lomb Inc Due to A...

The Issue: A software anomaly was identified where the system may automatically...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Bausch & Lomb Inc

Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris Recalled by...

The Issue: A software anomaly was identified where the system may automatically...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: Non-sterile drape Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Aircraft Medical Limited

Recalled Item: McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items...

The Issue: The blade retaining clip may be difficult to engage and thereby increase the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: LUNA Chest Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Pulsion Medical Inc

Recalled Item: Pulsiocath PiCCO ProAQT Monitoring Kit Recalled by Pulsion Medical Inc Due...

The Issue: Internal testing and investigation of the packaging revealed cracks and...

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

Class II — Potential Health HazardOngoing