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.
Smiths Medical is recalling Portex Unit Dose 5 ml Normal Saline because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Medline sterile water humidifiers because leaking containers may expose patients to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution because leaking containers may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Arjohuntleigh is recalling 231 RotoProne Therapy Systems because the proning arm buckle may be difficult to release, potentially delaying emergency patient access.
Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users to infectious agents.
Radiometer America Inc. is recalling ABL800 FLEX analyzers because creatinine measurements may be underestimated by up to 28%, potentially affecting patient safety during radiocontrast x-ray investigations.
Angiotech is recalling 504 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.
Angiotech is recalling specific lots of bone marrow biopsy needles because a manufacturing issue may have compromised the sterile seal on the blister trays.
GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.
Handpiece Headquarters is recalling 252 Henry Schein CU 1000 Halogen Curing Lights because the tip became too hot, causing heat sensations in patients.
Angiotech is recalling 500 units of Double Diamond J Type Bone Marrow Needles due to a manufacturing defect in the sterile seal on blister trays.
Angiotech is recalling 180 units of J Type Bone Marrow Needles due to a manufacturing issue affecting the sterile seal on blister trays.
GE Healthcare is recalling Centricity Universal Viewer Breast Imaging software because a display error could lead to incorrect patient diagnoses.
Stryker is recalling Naera Hospital Bassinet mattresses because air expansion at high altitudes may create gaps, posing a risk of patients rolling over.
Bard Medical Division is recalling 450 units of SureStep Foley Tray Systems because the sample ports may leak urine.
Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
Richard Wolf GmbH is recalling 873 Bronchoscope Tubes, Model Texas, because non-functional bonding points may loosen. The devices are used for respiratory tract investigation and therapy.
Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.
Angiotech is recalling 1,260 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.
Angiotech is recalling 1,404 Bone Marrow Biopsy Needles due to a manufacturing defect in the sterile seal on blister trays.
Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.
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