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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 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
DeRoyal is recalling C-Section Tracepacks containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released.
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.
Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.
27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.
Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.
SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.
Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.
Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.
Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.
CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.
GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.
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