Product Recalls in Delaware

Product recalls affecting Delaware — including food, drugs, consumer products, medical devices, and vehicles distributed to Delaware. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,482 recalls have been distributed to Delaware in the last 12 months.

48,330 total recalls
2,482 in last 12 months

Showing 2214122160 of 27,373 recalls

Medical DeviceDecember 19, 2014· Elekta, Inc.

Recalled Item: Monaco radiation therapy treatment planning system. The Monaco system is...

The Issue: Incorrect CT to ED when using the Monaco Image Statistics Tool.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Synthes, Inc.

Recalled Item: Synthes Electric Pen Drive (EPD) System Recalled by Synthes, Inc. Due to In...

The Issue: In May 2013, the original recall was initiated due to complaints the Hand...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Integra LifeSciences Corporation

Recalled Item: The MAYFIELD¿ Ultra 360 Base Unit for head positioner Recalled by Integra...

The Issue: Through an investigation of complaints, Integra found that there is the...

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· BD Biosciences, Systems & Reagents

Recalled Item: CD8 (Leu-2a) PE (In vitro diagnostic) Recalled by BD Biosciences, Systems &...

The Issue: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Becton Dickinson & Company

Recalled Item: BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula Recalled by...

The Issue: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Philips Medical Systems, Inc.

Recalled Item: Philips IntelliVue Information Center iX (release A.00 Recalled by Philips...

The Issue: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· St Jude Medical Cardiac Rhythm Management Division

Recalled Item: Merlin@home RF Remote Monitoring Transmitter Recalled by St Jude Medical...

The Issue: Transmitter may initiate a software reset resulting in backup operation in...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Spinal Elements, Inc

Recalled Item: Ti-Bond Marketing Literature/Labeling Recalled by Spinal Elements, Inc Due...

The Issue: Spinal Elements is recalling the Ti-Bond related brochures that includes...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Roche Diagnostics Operations, Inc.

Recalled Item: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Recalled...

The Issue: Chemical component of the F3 Fluid pack and environmental bacterial...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Ziemer Usa Inc

Recalled Item: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform...

The Issue: The devices were not shipped with the Starter Kits.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Sysmex Corporation

Recalled Item: The XN-Series modules (XN-10 Recalled by Sysmex Corporation Due to There is...

The Issue: There is a potential for elevated hemoglobin (Hgb) and impedance platelet...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Stryker Craniomaxillofacial Division

Recalled Item: MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm Recalled by Stryker...

The Issue: Potential for implant damage, implant cracking off/breaking intra-operatively.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Stryker Craniomaxillofacial Division

Recalled Item: MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants...

The Issue: Potential for implant deformation, implant mechanical stability too low,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Zimmer Gmbh

Recalled Item: Metasul Femoral Head - indicated for total hip arthroplasty for Recalled by...

The Issue: Potential compromise of the inner sterile tray. If a compromised tray is...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Zimmer Gmbh

Recalled Item: CoCr Femoral Head - A modular head component is used Recalled by Zimmer Gmbh...

The Issue: Potential compromise of the inner sterile tray. If a compromised tray is...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Stryker Craniomaxillofacial Division

Recalled Item: MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block...

The Issue: Potential for implant deformation, implant mechanical stability too low,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Zimmer Gmbh

Recalled Item: CoCr Femoral Head - indicated for hip arthroplasty for noncemented Recalled...

The Issue: Potential compromise of the inner sterile tray. If a compromised tray is...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Stryker Craniomaxillofacial Division

Recalled Item: MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB)...

The Issue: Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2014· Aesculap, Inc.

Recalled Item: Miethke Shunt System accessories Product Usage: - The Miethke Shunt Recalled...

The Issue: Some Miethke Shunt System accessories may have an incorrect MR safety symbol...

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

Class II — Potential Health HazardOngoing