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.
Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.
Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.
Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.
Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.
Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.
Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.
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