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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.
Boston Scientific is recalling VISIONIST X4 CRT-P Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ALTRUA 2 EL DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.
Stryker Neurovascular is recalling one Trevo XP ProVue System kit because the carton sleeve did not match the physical contents of the pack.
TEI Biosciences is recalling 4,081 units of PriMatrix acellular dermal tissue matrix because some Instructions for Use contained missing or duplicate pages.
Spineart SA is recalling 15 units of Tryptik 2 C-Plate Self Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
DeRoyal is recalling 226 sterile surgical kits because the included povidone iodine prep pads do not support the 36-month expiration date listed on the label.
Valeant Pharmaceuticals is recalling 418 SPAG-2 units and 808 nebulizers because some units failed to meet particle size specifications for ribavirin aerosol administration.
Spineart SA is recalling 120 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.
Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
Spineart SA is recalling 16 units of Tryptik 2 C-Plate Self Tapping screws distributed in California because the product labeling contains an incorrect sketch of a self-drilling screw.
Spineart SA is recalling 9 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling displays a sketch of a self-drilling screw instead of the correct self-tapping screw.
Spineart SA is recalling 8 units of Tryptik 2 C-Plate Self Tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
Spineart SA is recalling 54 units of Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.
Smiths Medical is recalling 29,232 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Philips is recalling 10 CombiDiagnost R90 X-ray systems because a protective earthing wire was removed and non-standard spacers were used.
Smiths Medical is recalling 22,080 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.
Encore Medical is recalling two units of the EMPOWR Tibial Punch because the guide did not sufficiently direct the punch, causing implants to be placed further back than intended.
CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.
Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs.
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