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.
Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.
Nephron Pharmaceuticals is recalling AsthmaNefrin Starter Kits because a component may dislodge and cause a choking hazard.
Nephron Pharmaceuticals is recalling EZ Breathe Atomizers because a component may dislodge, creating a choking hazard.
Nora Apothecary and Alternative Therapies, Inc. is recalling Renacidin Irrigation bladder irrigation products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nephron Pharmaceuticals is recalling EZ Breathe Medication Cups because a component may dislodge, creating a potential choking hazard.
Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.
Intuitive Surgical is recalling 8mm Precise Bipolar Forceps used with the da Vinci Surgical System because a component may dislodge, preventing proper cautery connection and causing loss of function.
Stryker Orthobiologics is recalling 17 units of the Aliquot Plunger, 8", due to reported catheter breakage during vertebroplasty procedures.
Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.
AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.
Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.
Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.
Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.
Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.
Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.
TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.
Alphatec Spine is recalling the Leucadia Autolok Polyaxial Pedicle Screw System because a tolerancing issue may prevent the rod from locking rigidly, potentially compromising spinal stability.
Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.
Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.
Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
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