Class IIOngoingZ-1818-2026
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
Integra LifeSciences C…NJApr 22, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 733–744 of 3,866 recalls
Class IIOngoingZ-1817-2026
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Increased rate of out-of-specification endotoxin results.
Integra LifeSciences C…NJApr 22, 2026
Class IIOngoingZ-1816-2026
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Increased rate of out-of-specification endotoxin results.
Integra LifeSciences C…NJApr 22, 2026
Class IIOngoingZ-1815-2026
3B Medical, Inc. recalls React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
3B Medical, Inc.OHApr 22, 2026
Class IIOngoingZ-1814-2026
Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction.…
Siemens Medical Soluti…PAApr 22, 2026
Class IIOngoingZ-1812-2026
Wilson-Cook Medical Inc. recalls Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Wilson-Cook Medical In…NCApr 22, 2026
Class IIOngoingZ-1811-2026
ARJOHUNTLEIGH POLSKA Sp. Z.O.O. recalls Arjo Tenor mobile passive patient lift
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the lo…
ARJOHUNTLEIGH POLSKA S…Apr 22, 2026
Class IIOngoingZ-1810-2026
Linkbio Corp. recalls LinkBio CORE Workstation
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Linkbio Corp.NJApr 22, 2026
Class IIOngoingZ-1809-2026
Beta Bionics, Inc. recalls iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
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) include certain icons displayed in the status bar that are active, ther…
Beta Bionics, Inc.CAApr 22, 2026
Class IIOngoingZ-1806-2026
Remel, Inc recalls Yeastone Broth
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Remel, IncKSApr 22, 2026
Class IIOngoingZ-1805-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical devi…
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding…
PHILIPS MEDICAL SYSTEM…Apr 22, 2026
Class IIOngoingZ-1804-2026
Stryker Sustainability Solutions recalls Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Stryker Sustainability…AZApr 15, 2026