Category
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.
DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.
Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.
Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.
Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.
Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.
Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.
Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.
Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.
Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.
Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.
Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.
Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.
Quest Medical, Inc. is recalling specific MPS Delivery Sets used with cardiopulmonary bypass equipment due to intermittent seal failures during use.
DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.
Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.
ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.
Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.
Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.
Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.
Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.
Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.
Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.
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