Category
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.
Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.
Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.
Medical Action Industries is recalling sterile operating room towels because lint is present on the product.
Medtest Holdings is recalling Pointe Scientific Hitachi AST Reagent because the package insert contains inconsistent linearity values in different sections.
Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.
Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion. The recall covers units distributed in the US and several international locations.
Arthrex is recalling specific SpeedBridge Implant Systems because some eyelets broke during insertion. The recall covers multiple batches distributed in the US and internationally.
Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.
Zimmer Biomet is recalling 8,154 Regenerex Series A Patella implants because the pegs may shear after surgery.
Abbott Medical Optics is recalling Healon medical devices because certain lots may contain microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon Pro ophthalmic solutions because manufacturing damage may have introduced microscopic glass particles.
Abbott Medical Optics is recalling Healon V due to a remote possibility of microscopic glass particles from manufacturing damage.
Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion.
Stryker is recalling 119 Medi-Therm Hyper/Hypothermia Systems because the water may reheat too quickly under specific operating conditions.
Abbott Medical Optics is recalling Healon Duet units because they may contain microscopic glass particles from manufacturing damage.
Roche Diagnostics is recalling 3,946 sample probes for cobas analyzers because corrosion on electrical contacts can disrupt liquid level detection, potentially causing sample carryover.
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System because some eyelets broke from the SwiveLock Anchor during insertion.
Abbott Medical Optics is recalling Healon GV due to a remote possibility of microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon 5 Pro ophthalmic solution because some units may contain microscopic glass particles from manufacturing damage.
Arthrex, Inc. is recalling specific Bio-SwiveLock SP Vented anchors because some eyelets broke during insertion.
Greatbatch Medical is recalling specific Linear Straight Broach Handles because they may break at the welds or lose the locating pin during use.
Arthrex is recalling specific batches of Bio Composite SwiveLock anchors because some eyelets broke during insertion.
Zimmer Biomet is recalling specific lots of Cobalt bone cement because a breach in the sterile Tyvek packaging could lead to loss of sterility.
Siemens is recalling 159 RAPIDPoint 500 Blood Gas Analyzers because a blank patient ID field may cause demographic errors.
Smith & Nephew is recalling 12 units of Peri-Loc Volar Distal Radius plates that were laser-etched as left plates but packaged as right plates.
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