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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.
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.
Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.
Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.
Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection and potential decreased battery longevity.
Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.
Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.
Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.
Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.
Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.
Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.
Philips is recalling ECG sync cables used with HeartStart monitors because electrical interference can cause misinterpretation of heart signals or interrupt pacing.
Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.
Precision Medical is recalling 315 Easy Dial Oxygen Regulators because the settings label may be off by one position, causing incorrect oxygen flow.
Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.
Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.
Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.
TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.
Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.
Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in Australia.
Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to reduced reactivity. The products were distributed in the US and Australia.
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