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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.
Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.
Varian is recalling High Energy Clinacs because photon beams may develop asymmetry, potentially causing minor patient injury or decreased disease control.
GE Healthcare is recalling 713 Innova fluoroscopic systems because a relay failure in the power distribution box can cause sudden loss of imaging modes without warning.
Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.
Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic because process deviations may have resulted in higher levels of pyrogens than permitted.
Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.
Insight Instruments is recalling 776 M.I.S. Ophthalmic Cannulas distributed in Indiana and Illinois because the device was misclassified.
Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.
Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.
Covidien is recalling Curity Staple Remover Kits because a supplier recalled OTC drug products used in the kits.
Bio-Rad is recalling Liquichek ToRCH Plus IgM Control - Positive because it contains detectable levels of HCV RNA originating from the manufacturing process.
Integra LifeSciences is recalling DuraGen Dural Graft Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.
Becton Dickinson is recalling BBL CDC Anaerobe 5% Sheep Blood Agar because the microbiological media may be contaminated with bacteria.
Becton Dickinson & Co. is recalling specific lots of Trypticase Soy Agar and MacConkey II-I plates due to potential bacterial contamination.
Karl Storz is recalling 9,432 cutting loops due to possible sterile packaging damage that may allow airborne contamination.
Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.
Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.
Summit Medical is recalling Myringotomy Lance Blades because the boxes contain the wrong type of blade.
Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.
Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging may allow airborne contamination.
Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.
Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.
American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.
QIAGEN is recalling artus CMV RG PCR kits because they may contain incorrect vials mixed with correct ones, potentially affecting test accuracy.
Karl Storz is recalling 9,432 units of pointed coagulation electrodes because damage to the sterile blister tray packaging may allow airborne contamination.
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