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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.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.
Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.
Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.
Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.
CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.
Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.
Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.
Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.
Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.
NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.
Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.
Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.
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