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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.
Cayenne Medical Inc. is recalling 976 units of AperFix AM Femoral Implants because they may break inside the femoral socket during orthopedic use.
Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.
Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.
Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.
FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.
Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.
Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.
Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.
GE Medical Systems is recalling 102 Discovery IGS 740 systems because X-ray abort errors may cause loss of imaging mode during fluoroscopic use.
Smiths Medical ASD Inc. is recalling 10 BCI Advisor Vital Signs Monitors because certain printing modes may not function properly.
bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous test results.
Dako North America Inc. is recalling 1,051 PD-L1 IHC 22C3 pharmDx kits to correct instructions for use regarding storage time for specific tissue sections.
Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.
FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.
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