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.
Zimmer, Inc. is recalling 16,380 units of Persona The Personalized Knee System 2.5 mm Female Screws due to potential stripping of the hex driver when used in cortical bone.
Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.
Intuitive Surgical is recalling 75 da Vinci Xi Patient Side Carts because a motor sensor failure can occur after a mid-procedure restart.
Siemens Medical Solutions is recalling 48 Symbia Intevo SPECT/CT systems because a rubber isolator may degrade over time, potentially leading to drive belt rupture.
Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.
Invivo is recalling 10 Philips MRI Patient Monitoring Systems because metal debris found during production could cause power failures and loss of patient monitoring.
Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.
Instrumed International is recalling 71 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.
Instrumed International is recalling 3,093 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.
Instrumed International is recalling 895 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
Baro-Therapies, Inc. is recalling 10 Rejuvenator Chambers because they were distributed without an approved 510(k).
Philips Medical Systems is recalling 79 Ingenuity CT scanners because they may mislabel the order of image exposures, potentially affecting clinical interpretation.
Instrumed International is recalling 156 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.
Instrumed International is recalling 83 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
Gendex Corp is recalling 651 eXpertDC intraoral x-ray units worldwide because spring link components in the articulated arm assembly broke during normal assembly.
Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.
Instrumed International is recalling 15 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.
GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.
Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.
Apollo Endosurgery is recalling 10 LAP-BAND AP Systems distributed past their expiration date in seven states.
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