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. 2,630 recalls have been distributed to Delaware in the last 12 months.

48,330 total recalls
2,630 in last 12 months

Showing 1138111400 of 27,373 recalls

Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 Recalled by Chembio...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP¿ Micro Reader II for use with the DPP¿ Recalled by Chembio...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Anjon Holdings

Recalled Item: Anjon Bremer Molded Crown. bone fixation fastener for spinal use. Recalled...

The Issue: High rate of galling of one threaded component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal Recalled by...

The Issue: Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· Beckman Coulter Biomedical GmbH

Recalled Item: DxA 5000 Recalled by Beckman Coulter Biomedical GmbH Due to The DxA 5000...

The Issue: The DxA 5000 instructions for use may be confusing regarding the re-use of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· Resource Optimization & Innovation LLC

Recalled Item: regard Migrating Indicator Recalled by Resource Optimization & Innovation...

The Issue: The firm received reports from customer that the Regard Migrating Indicator...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· FHC, Inc.

Recalled Item: FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Recalled by FHC,...

The Issue: An electrical sub-circuit was not properly connected. Its purpose is to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2020· Luminex Corporation

Recalled Item: Verigene Processor SP with assay Luminex Recalled by Luminex Corporation Due...

The Issue: An instrument failure mode that may result in a Blood Culture Gram Positive...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2020· Luminex Corporation

Recalled Item: Verigene Processor SP with assay: Luminex Recalled by Luminex Corporation...

The Issue: An instrument failure mode that may result in a Blood Culture Gram Positive...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2020· Access Scientific LLC

Recalled Item: POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Recalled by...

The Issue: Convenience kit mislabeled with the incorrect catheter effective length on...

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

Class III — Low RiskOngoing
Medical DeviceJune 12, 2020· Medtronic Xomed, Inc.

Recalled Item: Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The Recalled by...

The Issue: During internal testing execution of the next generation of Integrated Power...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 10, 2020· NuVasive Inc

Recalled Item: Nuvasive NVM5 EMG Module Recalled by NuVasive Inc Due to The NVM5 EMG Module...

The Issue: The NVM5 EMG Module kit intended for intraoperative neurophysiologic...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2020· EHOB, Inc.

Recalled Item: Expansion Control Overlay Recalled by EHOB, Inc. Due to QC inspection...

The Issue: QC inspection observed that a portion of the lot may have been contaminated...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2020· Bausch & Lomb Surgical, Inc.

Recalled Item: enVista one-piece hydrophobic acrylic toric intraocular lens Recalled by...

The Issue: The toric axis marks were misaligned (from the expected position in relation...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2020· New Standard Device Inc

Recalled Item: 1.8mm Truss Wire Recalled by New Standard Device Inc Due to 1.8mm truss...

The Issue: 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Accurian RF Ablation Recalled by Medtronic Sofamor Danek USA Inc Due to...

The Issue: Insertion difficulty of the probes. The probe was catching on a lip inside...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Accurian RF Ablation Recalled by Medtronic Sofamor Danek USA Inc Due to...

The Issue: Insertion difficulty of the probes. The probe was catching on a lip inside...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Accurian RF Ablation Recalled by Medtronic Sofamor Danek USA Inc Due to...

The Issue: Insertion difficulty of the probes. The probe was catching on a lip inside...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Accurian RF Ablation Recalled by Medtronic Sofamor Danek USA Inc Due to...

The Issue: Insertion difficulty of the probes. The probe was catching on a lip inside...

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

Class II — Potential Health HazardOngoing