Product Recalls in Nebraska

Product recalls affecting Nebraska — including food, drugs, consumer products, medical devices, and vehicles distributed to Nebraska. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,524 recalls have been distributed to Nebraska in the last 12 months.

49,150 total recalls
2,524 in last 12 months

Showing 1714117160 of 28,140 recalls

Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 218 cm (86") Appx 16.4 ml Recalled by ICU Medical, Inc. Due to Some devices...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter Recalled by ICU Medical,...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 112" Y-Type Blood Set w/170 Micron Filter Recalled by ICU Medical, Inc. Due...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· Brainlab AG

Recalled Item: AIRO Mobile CT System Recalled by Brainlab AG Due to Risk of unintended...

The Issue: Risk of unintended motion while the AIRO system is in transport mode.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· Roche Diagnostics Corporation

Recalled Item: Cobas 8000 Modular Series system Recalled by Roche Diagnostics Corporation...

The Issue: A software failure may incorrectly set the system settings to "default"...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· NXTHERA

Recalled Item: Rezum System Recalled by NXTHERA Due to Needle Bond may not be able to...

The Issue: Needle Bond may not be able to withstand the tension force applied when the...

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· 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· 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 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· 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 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 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· Molnlycke Health Care, Inc

Recalled Item: 9x15" Medium Utility Positioner with Cover Recalled by Molnlycke Health...

The Issue: Products may not meet specifications due to possible presence of metal shavings.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Molnlycke Health Care, Inc

Recalled Item: 7x10" Small Utility Positioner with Cover Recalled by Molnlycke Health Care,...

The Issue: Products may not meet specifications due to possible presence of metal shavings.

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 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 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· 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