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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.
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.
Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.
Medical Action Industries recalls General Purpose Instrument Trays due to potential flaking metal and brown spots on hemostats. These defects could contaminate surgical instruments.
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.
Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.
Cardinal Health is recalling Vicks 1.5-gallon vaporizers exposed to temperature excursions during shipping delays in February-March 2021, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Inlightened Partners LLC is recalling 926 inLight Medical LED Pads due to improper assembly of cord connectors, which may cause power interruptions and controller shutdown.
Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Medical Action Industries is recalling Mosquito Hemostats due to potential flaking metal and brown spots on the devices. The recall affects 23 boxes of surgical instruments distributed nationwide.
Exact Medical Manufacturing is recalling 17,545 units of a 6" x 48" Elastic Poly Probe Cover that lacks FDA 510(k) clearance for use in body openings. The product should not be used without proper FDA pre-market approval.
Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.
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