Category
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.
Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry may come loose, potentially causing noise.
Encore Medical is recalling two units of the EMPOWR Porous Knee System Tibial Punch because the locking guide failed to properly guide the punch, causing implants to be placed 2-3mm more posterior than intended.
Orthoscan is recalling Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.
Orthoscan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.
King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.
Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior than intended.
OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.
Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.
Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.
Encore Medical is recalling two units of the EMPOWR Tibial Punch because the locking guide failed to properly position the implant.
CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.
Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.
Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.
OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.
Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.
Amendia, Inc. is recalling 41 Mac Pin Non-Cannulated Screws because the packaging incorrectly lists the length as 460 mm, while the actual length is 60 mm.
ProSun International is recalling 75 Sundream 12 V tanning beds because the maximum tanning time has been reduced from 30 to 20 minutes.
Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.
Philips is recalling 412 Mobile Detector Holders for Stationary X-ray Systems because the lock mechanism may fail, causing the detector to drop.
Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.
Zimmer Biomet is recalling specific hip fracture stems because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Zimmer Biomet is recalling specific femoral distal assemblies because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself are correctly identified.
Zimmer Biomet is recalling CER BIOLOXD OPTION HD 32MM implants because the internal patient label may be incorrect, although the outer box and product are correctly identified.
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