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. 2,577 recalls have been distributed to Delaware in the last 12 months.

48,330 total recalls
2,577 in last 12 months

Showing 1664116660 of 27,373 recalls

Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue 500 with iScan Recalled by Optovue, Inc. Due to FDA determined that a...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 4000TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue with Normative Database Recalled by Optovue, Inc. Due to FDA determined...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iFusion Recalled by Optovue, Inc. Due to FDA determined that a 510(k) is...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 2200TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Medtronic Navigation, Inc.

Recalled Item: VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559...

The Issue: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· DePuy Orthopaedics, Inc.

Recalled Item: Concorde Lift Torque Limiting Handle. Must be used with supplemental...

The Issue: Potential for Intra-operative breakage of driver tips

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: Light Clip for Oracle Retractor Recalled by Synthes (USA) Products LLC Due...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· DePuy Orthopaedics, Inc.

Recalled Item: Concorde Lift Driver Shaft AO. Used with supplemental internal spinal...

The Issue: Potential for Intra-operative breakage of driver tips

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Titanium Calibrated Reaming Rod Recalled by Synthes (USA) Products...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 3.0 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Guide Rod Recalled by Synthes (USA) Products LLC Due to Possible lack...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 25, 2017· Arrow International Inc

Recalled Item: ARROW PICC powered by ARROW VPS Stylet Recalled by Arrow International Inc...

The Issue: Finished good kits may contain incorrect components. Kits that should...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 25, 2017· Arrow International Inc

Recalled Item: ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter...

The Issue: Finished good kits may contain incorrect components. Kits that should...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 25, 2017· Siemens Medical Solutions USA, Inc.

Recalled Item: Syngo Imaging version V31 (model # 10014063) is a Picture Recalled by...

The Issue: Siemens is releasing a letter to inform about potential data loss relevant...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 24, 2017· Sorin Group Italia SRL - CRF

Recalled Item: Platinium VR 1210 Recalled by Sorin Group Italia SRL - CRF Due to There is a...

The Issue: There is a possibility of overconsumption of certain PLATINIUM Implantable...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 24, 2017· Sorin Group Italia SRL - CRF

Recalled Item: Platinium DR 1510 Recalled by Sorin Group Italia SRL - CRF Due to There is a...

The Issue: There is a possibility of overconsumption of certain PLATINIUM Implantable...

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

Class II — Potential Health HazardOngoing