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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.
Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.
Zimmer, Inc. is correcting patient labels for Alloclassic SL Shafts manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for BioloX Option Ceramic Femoral Head Systems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for 18 CLS Stem implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.
Zimmer is correcting patient labels on 126 Alloclassic SL-Offset Stems made before March 2010 after four complaints that their reference and lot numbers differed from the correct product labels.
Zimmer Inc. is correcting patient labels for Wagner cone prostheses manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys Top-Loading System Cannulated Pedicle + Set Screws manufactured before March 2010 due to discrepancies between product and patient labels.
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer Inc. is correcting patient labels for Fitmore Hip Stems manufactured before March 2010 due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Anatomical Shoulder Humeral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems due to discrepancies in reference and lot numbers.
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.
Zimmer, Inc. is correcting patient labels for Metasul LDH Head Rx Sterile products manufactured before March 2010 due to discrepancies in reference and lot numbers.
Abbott Point of Care is recalling specific lots of Cliniqa Liquid QC Cardiac Marker Control for i-STAT because results may be generated below the lower value assignment range.
Zimmer, Inc. is correcting patient labels for NCB-PH Plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Kopf Adapter S Sterile products manufactured before March 2010 due to reference and lot number discrepancies.
Zimmer Inc. is correcting patient labels for NCB cancellous screws due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for NCB screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Clinical Diagnostic Solutions is recalling specific lots of Boule Con-Diff Hematology Control vials due to a received complaint.
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.
Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.
Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
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