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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.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.
Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.
Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.
Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.
CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.
Medline is recalling 136,080 ClearPro Trach T-Piece Closed Suction Catheters because the suction catheter can come apart from the connector during patient suctioning.
Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.
Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.
Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.
Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.
Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 units distributed nationwide and internationally.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.
Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.
CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.
Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which may compromise device sterility.
Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.
Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.
Ambra PACS and ProViewer versions 3.22.2.0 and 3.22.3.0 have a software defect where patient information edits may be lost during initial study processing due to a race condition between database systems.
Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.
OSSUR Power Knee prosthetics are being recalled because the battery may dislodge from the device. Approximately 190 units are affected across the United States.
Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.
Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.
Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.
Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address the issues.
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