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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.
GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.
GE Healthcare Optima 680 Expert CT systems may produce progressively rotated images during helical and cardiac scans. Affected images may require rescanning for accurate clinical interpretation.
Medline is recalling 102,561 medical convenience items manufactured using SafeAir Smoke Evacuation Pencils that Stryker previously recalled, distributed nationwide.
Medline is recalling 1,271 surgical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The affected kits were distributed nationwide, and healthcare facilities should discontinue use.
GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.
Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
BD recalled its COR MX instruments after an unauthorized actor accessed service credentials. The company is updating credentials to prevent future unauthorized access to product data and systems.
Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.
Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.
GE Healthcare is recalling operator console upgrades for certain CT systems due to a software defect causing progressive image rotation during scans. Rotations can reach up to 56 degrees and may require patient rescanning.
Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.
MEDLINE is recalling approximately 25,877 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.
Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.
Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.
MEDLINE is recalling 58,765 C-section convenience kits nationwide that contain SafeAir Smoke Evacuation Pencil components recalled by manufacturer Stryker. Affected kits have specific lot numbers.
Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.
MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.
WINGDERM ELECTRO-OPTICS LTD. is recalling all WLA-01 diode laser hair removal systems sold to US customers due to labeling non-compliances.
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