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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.
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.
Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.
Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.
American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during scanning.
Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.
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