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.
Medline is recalling the 120-inch latex-free ExtendFlex anesthesia circuit after complaints of leaks caused by cracks in the expandable tubing. The FDA has classified it Class I.
Medline is recalling ENT and laryngoscopy-bronchoscopy kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Medline is recalling multiple adult 120-inch expandable anesthesia circuits after complaints of leaks caused by cracks in the tubing. The FDA has classified it Class I.
Medline is recalling the latex-free Breathing Kit DYNJ10550 after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Medline is recalling ortho spine, total joint and kyphoplasty convenience kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.
Medline is recalling 96,406 breast and hernia convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Medline is recalling GYN Robotic and Robotic Prostate convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Medline is recalling open heart supplement and vascular kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
GE Healthcare is recalling 7,408 B105P, B125P, B105M, B125M and B155M patient monitors because certain batteries can lose the ability to hold charge, causing a loss of monitoring.
Medline is recalling two reprocessed LigaSure Blunt Tip sealer/dividers, 5 mm x 37 cm, because certain areas of the device can trap residual material that may become dislodged.
Medline is recalling 58,499 reprocessed LigaSure Impact sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
Medline is recalling 9,547 reprocessed LigaSure Maryland Jaw sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.
GE Healthcare is recalling 5,935 CARESCAPE ONE patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Applied Medical Technology is recalling NutraGlide 6 F-8 F x 90 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.
Medtronic Perfusion Systems is recalling 26 Affinity NT Oxygenators after identifying a unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Covidien is recalling two units of a VATS lobectomy box containing the Signia Small Diameter Curved Tip Intelligent Reload because internal components may move during firing.
Medline is recalling 18,117 reprocessed LigaSure Small Jaw instruments because certain areas of the device can trap residual material that may become dislodged.
GE Healthcare is recalling 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Techno-Path is recalling 51 units of Multichem ID-B positive control serum from a second lot because of potential negative recovery of the HBsAg analyte on the Alinity i platform.
Stryker Sustainability Solutions is recalling 22,476 reprocessed HARMONIC FOCUS shears because a manufacturing issue may leave them stuck in the on position, causing continuous activation.
Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.
Applied Medical Technology is recalling NutraGlide 5 F-6 F x 55 nasal feeding tubes with stylet and ENfit, REF NFT-05055-I, from one lot because the tube may be occluded.
Siemens Healthcare Diagnostics is recalling 2,802 units of the 3gAllergy Specific IgE Universal Kit because barcode orientation causes the instrument to misread tube positions.
Applied Medical Technology is recalling NutraGlide 5 F-6 F x 90 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.
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