Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.
Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.
Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.
ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.
Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
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