Recalls affecting Nebraska
Notices that name Nebraska in their distribution area, plus every nationwide recall — nationwide recalls reach Nebraska too.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Gluteal Implant Product Name: Gluteal Implant recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
DICOM Grid, Inc. Intelerad InteleShare software, with ProViewer component recall: Software intended to aid in diagnosing conditions
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are…
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Class II · 10 months ago
Medline Industries, LP Forcep, STD STR, Sterile Kelly, 5.5 recall: The items may have weak packaging seals that may result in a breach
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if…
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Class II · 10 months ago
Medline Industries, LP Scissors, OR, Sharp/Blunt, 5.5", Sterile recall: The items may have weak packaging seals that may result in a breach
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if…
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Class II · 10 months ago
Medtronic MiniMed, Inc. InPen App, Model/CFN Number: MMT-8061 recall: When app is uninstalled and reinstalled, insulin pen software issue causes
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
Cepheid Brand Name: Xpert¿ BCR-ABL Ultra Model/ recall: Invitro diagnostic test kits with specimens that have elevated white blood
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
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Class I · 10 months ago
GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system recall: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Silicone Carving Implant Product Name: Silicone recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class I · 10 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software LVP-SW-0005. Software recall: Software version 5.10.1 and earlier contain anomalies that have the potential
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Class III · 10 months ago
Datascope Corp. Cardiosave Hybrid recall: The IFU addendum updates the Vibration and Shock Table to reference
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Malar Implant Product Name: Malar Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Head AND Neck Tray recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Major Pack recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Calf Implant Product Name: Calf Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class I · 10 months ago
GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system recall: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
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Class III · 10 months ago
Datascope Corp. Cardiosave Rescue recall: The IFU addendum updates the Vibration and Shock Table to reference
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, EP LAB PK recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Midtown General Arteriogram recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
Abbott Laboratories Alinity ci-series System Control Module , REF: 03R70-01, 03R70-20 recall: Abbott Laboratories is recalling their Alinity ci-series System Control
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the…
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Class II · 10 months ago
Myofunctional Research Company USA Myosa for Kids KS1 REF MyOsaks1_Sb/Sp/Mb/Mp/Lb/Lc recall: Due to firm mistakenly distributing product within the U.S. without FDA
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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Class II · 10 months ago
Mindray North America Hardware configuration of the BeneVision Central Monitoring recall: When the Worstation of the BeneVision DMS has a specific hardware
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen…
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Class II · 10 months ago
Smith & Nephew, Inc. Biosure HA Screw, 6MM x 20 MM. Threaded metallic bone fixation recall: Removal of affected lot of screws due to labeling error
Removal of affected lot of screws due to labeling error.