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.
The Arrow peritoneal lavage catheter kit, 8 Fr, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 7,560 units affected.
Arrow AGBA PICC G4 Stylet kits and VPS access kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 11,358 units affected.
Giraffe and Panda Warmers with Integrated Resuscitation System are being recalled because a loosening blender knob shaft can cause delivery of an unintended oxygen concentration.
The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.
Giraffe OmniBed Carestations are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 23,430 units affected.
Medline procedure kits labeled Dr Fernandez are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
Philips MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.
Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.
Giraffe OmniBed Field Replaceable Units are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 265 units affected.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
The Mito Red Light Super Mobile near-infrared therapy device is being recalled because its lithium-ion battery may malfunction, causing it to catch fire or burst into flames.
Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 units affected.
Medline Tonsil Pack Cath procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 384 units are affected.
Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.
ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.
Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.
Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.
Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.
HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.
STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.
Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.
Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.
ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.
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