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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.
Medtronic is recalling 36 units of PAK Needle Beveled and Trocar Tips because packaging may contain incorrect needle types instead of the required combination.
Zimmer Biomet is recalling 49 Bone Dowell Harvest Tubes that were mislabeled as 8mm but are actually 9mm in size.
Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.
CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.
Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.
Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.
Almore International Inc. is recalling Microfil Composite Instruments because packaging labels incorrectly display a sterile symbol, although the devices are not sterile.
Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.
Olympus is recalling 863 Endoeye HD II video telescopes because a damaged temperature sensor can cause the tip to become abnormally hot.
Medtronic is voluntarily recalling Newport HT70 and HT70 Plus ventilators because they may shut down spontaneously without an alarm during normal operation.
Sysmex America Inc is recalling XN-10 and XN-11 hematology analyzers due to a risk of fire caused by misaligned internal protective sheets.
Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.
Natus Medical is recalling neoBLUE 2 phototherapy lights sold from 2003 to 2008 to prevent the use of replacement boards that allow higher light intensity than originally cleared.
Dale Medical Products is recalling Stabilock Endotracheal Adhesive Bases because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.
Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.
Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.
Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.
Bard Peripheral Vascular Inc. is recalling 570 units of MR GHIATAS Beaded Breast Localization Wire because they may be non-MR compatible instead of MR compatible.
Becton Dickinson is recalling 57,750 units of BD FlowSmart Set MiniMed Pro-set in California due to reports of bent catheters causing high blood glucose.
Terumo Medical Corporation is recalling SurFlo IV Catheters because a small percentage may have damage that allows the catheter to break during withdrawal.
Roho Inc. is recalling 5,646 units of ROHO High and Mid Profile cushions because the Smart Check tool may cause improper inflation, increasing the risk of skin or soft tissue injury.
Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.
Dale Medical Products is recalling Stabilock Endotracheal Tube Holders because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.
The Anspach Effort, Inc. is recalling 182 Bearing Sleeve, 10CM Curved units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.
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