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. 2,646 recalls have been distributed to Delaware in the last 12 months.

48,330 total recalls
2,646 in last 12 months

Showing 1068110700 of 27,373 recalls

Medical DeviceOctober 29, 2020· Prytime Medical Devices, Inc.

Recalled Item: PryTime Medical - ER-Reboa Plus Catheter Recalled by Prytime Medical...

The Issue: There is a potential that catheters may have incorrectly marked balloon and...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2020· Chromsystems Instruments & Chemicals GmbH

Recalled Item: 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva...

The Issue: Calibrator lots may not meet stability criteria and could result in...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2020· Chromsystems Instruments & Chemicals GmbH

Recalled Item: MassChrom Cortisol Recalled by Chromsystems Instruments & Chemicals GmbH Due...

The Issue: Control lots may not meet stability criteria and could result in increased...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2020· Chromsystems Instruments & Chemicals GmbH

Recalled Item: MassChrom Cortisol Recalled by Chromsystems Instruments & Chemicals GmbH Due...

The Issue: Control lots may not meet stability criteria and could result in increased...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2020· Philips Ultrasound Inc

Recalled Item: All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G Recalled...

The Issue: The manufacturer has determined that with certain uncommon workflows there...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2020· GE Healthcare, LLC

Recalled Item: MAC VU360 Recalled by GE Healthcare, LLC Due to Incorrect patient...

The Issue: Incorrect patient identification and/or patient demographic errors.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2020· Mani, Inc. - Kiyohara Facility

Recalled Item: MANI Infusion Cannula 23G S - Product Usage: for use Recalled by Mani, Inc....

The Issue: Dimensions of the Luer connector parts out of specification, may cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2020· Mani, Inc. - Kiyohara Facility

Recalled Item: MANI TROCAR KIT 23G S - Product Usage: for use Recalled by Mani, Inc. -...

The Issue: Dimensions of the Luer connector parts out of specification, may cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1300 Analyzer - Product Usage: automated Recalled by Siemens...

The Issue: Test Definition scanning may reset custom settings to defaults causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1600 Analyzer - Product Usage: automated Recalled by Siemens...

The Issue: Test Definition scanning may reset custom settings to defaults. When a 2D...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Hardy Diagnostics

Recalled Item: Viral Transport Medium Recalled by Hardy Diagnostics Due to There is a...

The Issue: There is a potential for contamination within Viral Transport Media. Use of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) PRO+ System. With the following model numbers: a. Recalled by...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Biomeme, Inc.

Recalled Item: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in Recalled by...

The Issue: The firm has become aware of nine reports by a single customer that the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Becton Dickinson & Company

Recalled Item: BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for Recalled by Becton...

The Issue: Product shelf cartons incorrectly labeled as products intended for the Latin...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Intuitive Surgical, Inc.

Recalled Item: Box Label: ION Fully Articulating Catheter Recalled by Intuitive Surgical,...

The Issue: The distal tip ring of the fully articulating catheter may become dislodged...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Coloplast Manufacturing US, LLC

Recalled Item: Titan Pump - Product Usage: indicated for male patients suffering Recalled...

The Issue: Potential increased occurrence of pump fracture over the lifetime of the device.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Mako Surgical Corporation

Recalled Item: Mako Integrated Cutting System (MICS) Handpiece Recalled by Mako Surgical...

The Issue: Stryker has discovered a characterization issue associated with the Mako...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 21, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee floor Recalled by Siemens Medical Solutions USA, Inc Due to Some...

The Issue: Some electronic components within the generator were equipped with an...

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

Class II — Potential Health HazardOngoing