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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.
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.
Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.
Bayer is recalling 5 million bottles of Contour Next Control Solution because improper shaking may cause inaccurate blood glucose meter readings.
Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.
Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error messages.
Abbott Electrophysiology is recalling 86 units of FIRMap 60mm Catheters because the expiration date was incorrectly printed on the labels.
Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.
Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.
Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.
Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.
Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.
Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.
Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.
GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.
Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.
Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.
Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.
Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.
The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.
The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.
Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.
RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.
Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.
PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.
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