Recalls published in April 2026
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in April 2026, newest first.
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Class II · 6 months ago
LinkBio recall: The CORE Workstation may display an incorrect "Planning Date " when viewing
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
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Class II · 6 months ago
Integra LifeSciences Corp. Cytal Burn Matrix 7x10 cm. Product ID: BMM0710 recall: Increased rate of out-of-specification endotoxin results
Increased rate of out-of-specification endotoxin results.
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Class I · 6 months ago
B Braun Medical Inc B. Braun Hemodialysis Bloodlines, Streamline Fresenius FOR Davita 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 I · 6 months ago
B Braun Medical Inc B. Braun 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
Centurion Circumcision Kit, Medline Kit Number/SKU CIT7050F recall: On lot of Sterile Circumcision Kits was distributed without the required
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
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Class II · 6 months ago
Siemens Medical Solutions USA, Inc ARTIS Pheno VE30A and VE40A, Model 10849000 recall: During 3D acquisitions, lighter and darker patient images may be captured
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of…
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Class II · 6 months ago
Philips Spectral CT on Rails recall: Philips has identified three software issues: 1. During a continuous CT (CCT)
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the…
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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