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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.
Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.
Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.
Envisiontec US LLC recalled 795 units of FLEXCERA SMILE dental resins manufactured between April 2021 and September 2021 because they were produced in a non-FDA-registered facility and falsely labeled as German origin.
Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
E25Bio COVID-19 diagnostic tests have been recalled following nationwide distribution without FDA authorization or approval. The distributed units lacked sufficient directions and quality controls needed for safe diagnostic use.
GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.
GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were affected.
Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold worldwide.
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.
GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.
Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.
GE Healthcare is recalling 17,228 MRI systems with a potential cryogen ventilation system defect that may not meet regulatory venting requirements.
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.
The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
Baxter is recalling 116,628 peritoneal dialysis transfer sets worldwide because certain cleaning chemicals can damage the device, potentially causing leaking or cracking.
GE Healthcare is recalling 17,228 of its 1.5T SIGNA HDe MR imaging systems because the cryogenic ventilation system does not meet required venting standards.
GE Healthcare is recalling 17,228 SIGNA Artist MRI systems due to a potential defect in the cryogen ventilation system that may not meet safety venting requirements.
Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets to leak or crack.
GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.
GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that may not meet required venting specifications.
GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.
GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. and internationally.
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