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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.
Medline Industries is recalling 118 units of Triage BNP calibrators shipped with ice instead of dry ice, risking product degradation.
Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.
Ameditech is recalling 99,900 units of First Check 7 Panel Drug Cups because the products failed to consistently detect all compounds at labeled levels.
Ameditech is recalling ToxCup Drug Screen Cups because they may fail to consistently detect all substances at labeled levels.
Ameditech Inc is voluntarily recalling 1,325 units of Oratect III Oral Fluid Drug Screen Devices due to a Class II safety concern.
Greiner Bio-One is recalling VACUETTE blood collection tubes because they experienced an issue with separation and clotting.
Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to inconsistent detection of compounds.
Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.
Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.
Ameditech Inc is recalling specific drug screening components because they failed to consistently detect compounds at labeled levels.
Cardinal Health is recalling pre-operative decolonization kits that contain only one nasal swab instead of the four required for proper treatment.
Ameditech is recalling 41,340 units of First Check 2 Panel Drug Cups because the products failed to consistently detect compounds at labeled levels.
Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Ameditech is recalling Fastect II Drug Screen Dipstick Tests because they failed to consistently detect compounds at labeled levels.
Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.
Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.
Ameditech is recalling 47,005 units of First Check 14 Panel Drug Cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
GE Healthcare is recalling 62 Discovery NM 630 systems because rotor bearing screws were found loose on the detector.
LivaNova is recalling 94 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.
ArthroCare Corporation is voluntarily recalling 15,559 units of Smith&Nephew SmartStitch PerfectPasser Connectors because a manufacturing error may cause the upper jaw to detach during use.
LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.
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