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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.
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.
Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.
Fresenius Medical Care is recalling Dialyzer Optiflux 160NRe units nationwide due to potential internal blood leaks caused by cracked polyurethane in the dialyzer material.
IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.
GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.
Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.
Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.
GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.
GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.
Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.
Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.
Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.
Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.
Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.
Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.
3B Medical recalled 5,010 Ultrasoft Oxygen Cannula units (Model O2U2012, Lot 20170403) distributed in Massachusetts and Arkansas because they were shipped after their expiration date.
GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.
GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.
GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.
Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.
Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.
Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.
Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.
Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.
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