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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 BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.
CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.
Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects 4,080 units distributed in the US and internationally.
CareFusion recalls the BD Pyxis Med ES Auxiliary medication cabinet due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Stryker Corporation is recalling surgical burs that may be packaged with incorrect labels, causing a mismatch between the device model inside and the label. Approximately 491 affected devices were distributed worldwide.
Integra LifeSciences is recalling CODMAN CERTAS Plus Programmable Valves (Model 828810PL) due to incorrect product descriptions on internal and external labels. The mislabeling affects 170 units distributed across the US and several international locations.
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects approximately 2,190 units in the US.
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.
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