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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.
Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
The Anspach Effort, Inc. is recalling 10 electric foot controls used for bone cutting because the cable lacks a shield connection.
Aesculap, Inc. is recalling two Columbus 4-IN-1 Femoral Cutting Guide Instruments because the laser markings for size identification are incorrect, although the instruments are correctly dimensioned.
The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.
Boston Scientific is recalling LeVeen Standard Needle Electrode Systems because the Portuguese instructions for use are incorrect. The recall affects units distributed in Brazil, Portugal, and Hong Kong.
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4.0 and later due to potential calculation errors in the Online Entry application.
Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may function incorrectly when nitrous gas flows without oxygen.
Baxter Healthcare is recalling Clearlink Buretrol Solution Sets because the ball-valve feature may fail, allowing air to enter the tubing.
Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.
Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.
Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.
Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.
Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.
Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.
Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.
Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.
Accutron is recalling 220 Newport Portable Analgesia Gas Machines because the flowmeter functions incorrectly when nitrous gas flows without oxygen.
Kardium is recalling 480 units of the TORQ Sternal Closure Device because a metal part may dislodge during use.
3M is recalling Steri-Vac 5XL and 8XL gas sterilizers because the electrical grounding mechanism did not meet safety standards.
BioMérieux is recalling PREVI Isola Systems because they may fail to dispense specimens, leading to false negative microbiological test results.
Winco Mfg. is recalling Caremor Cliner patient recliners because a back frame may not snap properly onto the chair frame.
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