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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.
Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.
Oakworks Inc is recalling PX200 Emergency Relief Beds due to labeling defects. The product label is missing the UDI number and states an incorrect weight capacity of 500 lbs instead of the actual 400 lb limit.
Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.
GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.
Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.
MedMinder Medication Dispensers will no longer connect to the emergency alert system for all models. The device's emergency communication capability has been discontinued for approximately 2,701 units nationwide.
Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.
ROi CPS LLC has recalled the Regard GS0098C bronchoscopy kit because it contained Medline Endoscopy Bedside Cleaning products that were previously recalled.
BSN Medical Inc is recalling JOBST Compri2 and Compri2 lite compression bandages because the folding boxes containing the products are mislabeled. The actual products and immediate packaging are correctly labeled.
New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.
Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.
Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.
MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
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