Recalls affecting North Carolina
Notices that name North Carolina in their distribution area, plus every nationwide recall — nationwide recalls reach North Carolina too.
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Class I · 6 months ago
B Braun Medical Inc B. Barun Hemodialysis Bloodlines recall: Potential for the accumulation of small air bubbles in the arterial line
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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Class II · 6 months ago
Integra LifeSciences Corp. Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505 recall: Increased rate of out-of-specification endotoxin results
Increased rate of out-of-specification endotoxin results.
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Class II · 6 months ago
Clariance-SAS Brand Name: Elegance¿ Anterior Cervical Plate Product Name: Elegance 1 recall: Due to a quality issue regarding the presence of burr on the finished
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
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Class II · 6 months ago
Beta Bionics, Inc. iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software recall: it was found that in versions 1.3.7, 1.4.2, and 1.4.3
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI)…
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Class II · 6 months ago
Philips AneurysmFlow recall: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA)
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the…
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Class II · 6 months ago
Therakos Development Limited Brand Name: Cellex Photopheresis System Product Name recall: Increased difficulty in installing the centrifuge bowl onto the centrifuge
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to…
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Class II · 6 months ago
Wilson-Cook Medical Inc. Instinct Plus Endoscopic Clipping Device REF: G58010 recall: Due to increased in complaints their is the potential for endoscopic clipping
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
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Class II · 6 months ago
Integra LifeSciences Corp. Cytal Burn Matrix 10x15 cm. Product ID: BMM1015 recall: Increased rate of out-of-specification endotoxin results
Increased rate of out-of-specification endotoxin results.
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Class II · 6 months ago
Gentuity HF-OCT Imaging System Model G10-01 recall: The potential for repeated frames during HF-OCT pullback when using
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx…
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Class II · 6 months ago
Remel, Inc Yeastone Broth, 11ML, 10/BOX YY3462 recall: Products may report incorrect AST results during quality control. Health
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another…
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Class I · 6 months ago
Insulet Corporation Omnipod 5 Pods. Model/ recall: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod…
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Class II · 6 months ago
ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo Tenor mobile passive patient lift recall: An internal component of the actuators in a certain production batch
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst…
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Class II · 6 months ago
3B Medical, Inc. React Health Phoenix 5L Oxygen Concentrator recall: Devices which did not meet internal quality specifications were inadvertently
Devices which did not meet internal quality specifications were inadvertently distributed.
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Huons Co., Ltd. Lidocaine HCl Injection, USP, 2%, 100 mg/5mL , 5 mL Single-Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. MGC Health recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Island Kinetics, Inc. d.b.a. CoValence Laboratories Blemish Spot Treatment 1% recall: Failed Stability Specifications
Failed Stability Specifications
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Class II · 6 months ago
Owen Biosciences Inc. HydroPeptide Clear Alliance Serum, 2.5% Benzoyl Peroxide recall: Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Huons Co., Ltd. Lidocaine HCl injection, USP, 1% 50mg/5mL , 5 mL Single Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 6 months ago
Avantor Performance Materials LLC Magnesium Chloride, 6-Hydrate, Crystal recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Huons Co., Ltd. Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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Class III · 6 months ago
Island Kinetics, Inc. d.b.a. CoValence Laboratories Skin Rehab recall: Subpotent Drug
Subpotent Drug