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. 2,512 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,512 in last 12 months

Showing 1246112480 of 27,645 recalls

Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: MICRO-PSD EXTERNAL BEAM PHOTON Recalled by Angiodynamics, Inc. Due to May...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation stand-alone software treatment planning system Recalled by...

The Issue: Editing a static arc beam may unexpectedly set the MU of the beam to its...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Diagnostica Stago, Inc.

Recalled Item: STA SYSTEM CONROL N + P (ref. 00678) Recalled by Diagnostica Stago, Inc. Due...

The Issue: A positive bias was confirmed to exists on the STA - Unicalibrator levels...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Diagnostica Stago, Inc.

Recalled Item: STA UNICALIBRATOR (ref. 00675) Recalled by Diagnostica Stago, Inc. Due to A...

The Issue: A positive bias was confirmed to exists on the STA - Unicalibrator levels...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Leica Microsystems, Inc.

Recalled Item: BOND Polymer Detection Kit Recalled by Leica Microsystems, Inc. Due to BOND...

The Issue: BOND Polymer Detection kits (DS9800) were held out of storage longer than...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Boston Scientific Corporation

Recalled Item: Habib EUS RFA Recalled by Boston Scientific Corporation Due to During...

The Issue: During testing on the Habib EUS RFA device, a temperature increase was...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Boston Scientific Corporation

Recalled Item: Habib EUS RFA Recalled by Boston Scientific Corporation Due to During...

The Issue: During testing on the Habib EUS RFA device, a temperature increase was...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Baxter Healthcare Corporation

Recalled Item: Revaclear Capillary Dialyzer 300 Recalled by Baxter Healthcare Corporation...

The Issue: There is the potential presence of particular matter in the header caps of...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Tytek Medical Inc

Recalled Item: PneumoDart Recalled by Tytek Medical Inc Due to A defect involving an...

The Issue: A defect involving an occluded needle was discovered during a training exercise.

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2019· Tosoh Smd Inc

Recalled Item: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment...

The Issue: The AIA-2000 bar code scanners depend on the quiet zone to help identify the...

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

Class III — Low RiskOngoing
Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T....

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 13, 2019· Linet Spol. S.r.o.

Recalled Item: Eleganza 5 (AC powered adjustable bed) Recalled by Linet Spol. S.r.o. Due to...

The Issue: A component used within the side rail mechanism may malfunction, resulting...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 13, 2019· GETINGE US SALES LLC

Recalled Item: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion...

The Issue: Sterile barrier system may be compromised

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2019· Aesculap Implant Systems LLC

Recalled Item: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with...

The Issue: Nonfunctional key due to the potential for damage to the key pins cause by...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Nextremity Solutions

Recalled Item: Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST Recalled by...

The Issue: Components 2mm shorter than indicated on the package label

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Nextremity Solutions

Recalled Item: Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST Recalled by...

The Issue: Components 2mm shorter than indicated on the package label

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

Class II — Potential Health HazardOngoing