Recalls affecting New Jersey
Notices that name New Jersey in their distribution area, plus every nationwide recall — nationwide recalls reach New Jersey too.
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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 II · 10 months ago
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class II · 10 months ago
Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap recall: Treatment reagent functionality in respiratory specimens liquification cannot
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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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 II · 10 months ago
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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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
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
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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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.
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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 II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. Lidocaine HCI 2% and Epinephrine 1:100,000 recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
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Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. Cook-Walte, Carbocaine 3% recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
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Class III · 10 months ago
Somerset Therapeutics LLC Cisatracurium Besylate Injection USP, 10 mg/5 mL* recall: Subpotent product:out of specification assay results observed during long
Subpotent product:out of specification assay results observed during long term stability testing.
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Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. OraVerse, Injection, 0.4 mg/1.7mL recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
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Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. 2% Xylocaine Dental with Epinephrine 1:100,000 recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
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Class III · 10 months ago
Somerset Therapeutics LLC Cisatracurium Besylate Injection USP, 200mg/20mL* recall: Subpotent product:out of specification assay results observed during long
Subpotent product:out of specification assay results observed during long term stability testing.
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Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. 3% Polocaine Dental recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges