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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.
Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.
Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.
Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.
Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.
Medline Industries is recalling ten models of sterile convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. The seal failure could compromise sterility of the kits.
CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.
Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.
Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.
Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.
Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.
Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.
Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.
Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.
Philips is recalling certain DXR System DuraDiagnost 4.1 stationary X-ray systems due to a potential for the collimator to fall if installed incorrectly.
GE Medical Systems is recalling certain Venue Fit ultrasound systems because the battery can develop an internal failure that could result in smoke or fire.
Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.
Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Baxter Healthcare is recalling certain Welch Allyn Connex Integrated Wall System blood pressure cuff configurations due to an undeclared natural rubber band in the packaging that may cause allergic reactions in individuals with latex sensitivity.
Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver units because they are missing laser marked depth markings, which may affect proper surgical placement.
Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.
Medline Industries is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. Weak seals may compromise product sterility.
Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to the potential for early X-ray tube failure caused by excessive thermal load on the anode. The affected units were distributed nationwide in California, New Jersey, and Puerto Rico.
Conformis is recalling certain Cordera Hip acetabular liners from Lot 1788258 due to incorrect labeling. Units labeled as standard liners actually contain hooded liners, creating a mismatch between the label and the product.
Baxter Healthcare Corporation is recalling Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits worldwide due to undeclared natural rubber in the packaging. Consumers with latex allergies may experience allergic reactions if exposed.
GE Medical Systems is recalling certain Venue Go ultrasound system models worldwide due to potential battery internal failure that could result in smoke or fire.
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