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.
Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Centurion Medical Products Corporation is recalling specific sterile pitcher kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
Centurion Medical Products Corporation is recalling various sterile dressing change trays and procedure kits because incomplete seals may compromise sterility.
Centurion Medical Products is recalling specific biopsy trays because incomplete sterile package seals may compromise sterility.
Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.
Centurion Medical Products Corporation is recalling HT5555A Hyperalimentation & Dressing Change Trays due to incomplete seals that may compromise sterility.
Centurion Medical Products is recalling various sterile surgical trays and packs because incomplete seals may compromise sterility.
Centurion Medical Products is recalling specific Circumcision Tray Kits because incomplete seals on the sterile packaging may compromise sterility.
Centurion Medical Products Corporation is recalling specific dressing trays and medical packs because incomplete seals may compromise sterility.
Centurion Medical Products is recalling specific sterile biopsy and arthrogram trays due to incomplete seals that may compromise sterility.
Ethicon is recalling specific VICRYL sutures because braid fraying may reduce tensile strength. The recall covers 23,688 units distributed in the US and Puerto Rico.
Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cook Inc. is recalling 15 units of Fixed Core Straight Safety Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients.
Cook Inc. is recalling Percutaneous Pigtail Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Centurion Medical Products Corporation is recalling Debridement Trays because incomplete seals on the sterile package may compromise sterility.
Centurion Medical Products Corporation is recalling Skin Prep Trays due to incomplete seals on the sterile package, which may compromise sterility.
Centurion Medical Products Corporation is recalling specific lots of sterile skin prep trays because incomplete seals may compromise sterility.
Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Centurion Medical Products Corporation is recalling specific umbilical catheter trays because incomplete seals on the sterile package may compromise sterility.
Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.
Implant Direct Sybron is recalling 72 Legacy 3 dental implants because some packages contain incorrect implants, which could lead to surgery rescheduling.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound Transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings stay within the stated accuracy range.
Intuitive Surgical is recalling 286 Da Vinci Xi EndoWrist Monopolar Curved Scissors because they are not recognized by the integrated electrosurgical unit, preventing the activation of monopolar energy.
PediaLift LLC is recalling 11 PediaLift Access Devices because the firm could not obtain a satisfactory Certificate of Conformance from the original vendor regarding labeling requirements.
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