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.
Medtronic Xomed is recalling Lamicel 10PK 10MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.
Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.
Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.
Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.
Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.
Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG studies.
Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.
Abbott Medical is recalling 470 radiofrequency cannulas that were incorrectly labeled with a 5mm active tip length instead of 10mm.
Ortho Clinical Diagnostics is recalling VITROS 7% BSA diluent because it may become unstable when stored in a 2mL cup for seven days.
Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.
Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.
AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings due to potential mold contamination. The affected sterile dressings were distributed to nine states.
Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.
GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.
Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.
Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.
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