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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.
Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning procedures.
CareFusion bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning procedures.
CareFusion bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.
Carefusion V. Mueller bipolar forceps are recalled because their instructions are missing information on power supply interface and cleaning procedures. Users should obtain the complete manufacturer instructions.
CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.
Carefusion recalled certain bipolar forceps due to incomplete Instructions For Use. The IFU was missing content about the device's power supply interface and cleaning and maintenance procedures.
Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface and maintenance procedures.
Carefusion is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface and maintenance procedures.
Medical Action Industries is recalling Port Access Kits that are incorrectly labeled as IV Start Kits on the individual kit label. The case label is correct; mislabeling could cause confusion about the product's identity.
Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).
CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.
Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.
Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.
CareFusion bipolar surgical forceps are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.
CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.
Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on power supply interface and cleaning and maintenance procedures.
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.
GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.
Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.
Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.
Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
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