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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.
Centurion Medical Products is recalling IV Securement Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.
Centurion Medical Products is recalling Infusa Port Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.
Becton, Dickinson and Company is recalling 12 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Becton, Dickinson and Company is recalling specific BD FACSLyric Flow Cytometers used with BD Trucount Tubes due to potential electronic errors that may result in falsely high absolute cell counts.
Centurion Medical is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.
Centurion Medical Products Corporation is recalling Port and IO Access Dressing Kits because they include a connector recalled for potential fluid droplet separation.
Centurion Medical Products is recalling CAP Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.
Stryker Neurovascular is recalling 190 8F Balloon Guide Catheters because they were incorrectly packaged in 9F Balloon Guide Catheter packaging. The affected lot was distributed only outside the United States.
Repro-Med Systems is recalling 1,990 pouches of 26-gauge subcutaneous safety needle sets due to mislabeled needle lengths.
GE Healthcare is recalling 599 Achilles Insight Bone Sonometers because they were shipped with European power cords that do not meet local safety requirements for protective earth connection.
K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.
Leica Biosystems is recalling three Aperio CS2 CE IVD scanners due to incorrect sensors that may affect image quality and analysis results.
Becton Dickinson is recalling BD Microtainer PST Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volume and erroneous test results.
Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.
Arrow International Inc. is recalling 3,143 Pediatric Two-Lumen Central Venous Catheterization Kits due to a labeling error on the lidstock.
Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.
GE Healthcare is recalling 241 Achilles Express Bone Sonometers because they were shipped with power cords that do not meet local safety requirements for protective earth connection.
Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.
Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.
Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.
Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.
Medtronic Vascular is recalling 12 units of the SHERPA NX Active Guiding Catheter due to a potential for extensive loss of primary segment material, which exposes underlying stainless-steel braid wires.
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