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.
Maquet is recalling 667 PowerLED 300 Concealed Lighting Systems because the spring arm may detach and fall, posing a potential injury risk.
Abiomed is recalling 3,322 Automated Impella Controllers worldwide due to firmware and software defects that affect pressure signal accuracy and system reliability.
Medline is recalling Healthmark Instrument Channel Brush kits due to potential sharp edges that could cause cuts, abrasions, or infection.
Midmark Corporation is recalling 20 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.
Medline is recalling 234 neurological surgery kits nationwide due to potential endotoxin variability that may cause adverse health reactions.
Midmark Corporation is recalling 33 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.
New York Embroidery Studio is recalling 5,400 Trinity Non-Surgical Isolation Gowns because they do not consistently meet minimum liquid-barrier performance requirements.
Cardinal Health is recalling 17,503 Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.
Olympus is recalling 2,142 BiCOAG Hemostasis Probes because a manufacturing error may cause the ceramic tip to detach.
Midmark Corporation is recalling 153 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.
SeaSpine Orthopedics is recalling 270 units of the Mariner Deformity Extended Polyaxial Head because the proximal thread depth is out of design specification.
Intervascular is recalling Cardioroot Woven Collagen Coated Vascular Grafts because the product failed to meet acceptance criteria for Integral Water Permeability.
Medline is recalling 486 craniotomy convenience kits due to potential endotoxin variability that may cause adverse health reactions.
Biomerieux Inc is recalling VITEK 2 AST-N461 test kits due to card pouch damage that may cause false resistant results, potentially leading to less effective antibiotic treatments.
Midmark Corporation is recalling IQvitals Zone devices because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.
Medline is recalling 695 convenience kits containing neurological sponges due to potential endotoxin variability that may cause adverse health reactions.
Medline Industries is recalling 4,013 neurological surgery kits due to potential endotoxin variability that may cause adverse health reactions.
Cardinal Health 200, LLC is recalling Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.
Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments exceed system memory.
Ventec Life Systems is recalling 25 HomeFill Oxygen Systems because the cylinders lack required medical gas labeling.
Baxter Healthcare is recalling six PRO+ 40-inch MRS Surface mattresses due to errors in the Unique Device Identification (UDI) label text.
Criticare Technologies is recalling 1,007 nGenuity Patient Monitors because a setup error renders the CO2 monitoring function inoperable, potentially delaying procedures.
Baxter Healthcare is recalling two VOLARA systems because contamination in test equipment may have affected flow rate accuracy. Affected devices were returned and confirmed to meet specifications.
DeRoyal Industries is recalling Myocardial Probes that contain an 18mm needle instead of the specified 15mm needle.
Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.
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