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.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 18x22cm devices because the suture material degraded, causing them to fail burst specifications.
Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
GE Healthcare is recalling Aisys anesthesia systems because they may fail to transition to backup ventilation if a patient stops breathing spontaneously.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them to fail burst specifications.
Stryker is recalling Spirit Select Beds with high rail siderails due to non-compliance with safety standards and a potential risk of entrapment.
bioMérieux is recalling NucliSENS easyMAG Lysis Buffer because some eluates become colored due to remaining hemoglobin.
Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
Stryker Sustainability Solutions is recalling two reprocessed diagnostic EP catheters because they were identified as item # D134903 but are actually item # D134909, which is not approved for reprocessing.
Medtronic is recalling 138 units of INFUSE Bone Graft X Small Kits because they may contain two absorbable collagen sponges instead of one.
Johnson & Johnson Surgical Vision is recalling 17 expired Abbott TECNIS intraocular lenses distributed in seven US states.
Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.
Arrow International is recalling 3,640 units of the AGB+ Multi-Lumen CVC Kit because some labels incorrectly state the spring-wire guide size as .032 instead of .025.
Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.
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