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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.
Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.
DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.
Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.
Boston Scientific is recalling ROTAWIRE Drive guidewires due to potentially open pouch seals that could compromise product sterility. Affected units were distributed in the US, territories, Japan, and Canada.
Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.
B Braun Medical Inc is recalling conductivity sensors used in Dialog and Dialog+ hemodialysis systems due to potential cracks that could cause dialysate circuit leaks, affecting ultrafiltration during treatment.
CLARAVUE Pre-wired ECG electrodes may not meet electrical safety standards for defibrillation, potentially delivering an ineffective electrical charge during emergency use. This is a Class II recall affecting devices nationwide.
B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.
Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.
Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.
Merit Medical Systems is recalling 36,445 Access-9 Large Bore Hemostasis Valves due to an internal gap that can trap the guidewire, potentially delaying medical procedures.
Deerfield Imaging recalls the Trumpf Mount Clamp Assembly component used in surgical head fixation devices. The clamp may deflect during use and become difficult to loosen after procedures, potentially requiring surgical intervention.
The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.
Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.
Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.
GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.
The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.
Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.
Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide because the mask cuff may disconnect from the breathing tube.
Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.
Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.
Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.
LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.
Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.
The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.
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