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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.
MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.
Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.
Covidien is recalling certain Signia surgical stapler reloads due to unsecured components that can cause uncontrolled articulation during use, potentially disrupting the staple line. The recall affects 3,023 units distributed worldwide.
Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.
Covidien is recalling approximately 11,796 Auto Suture Blunt Tip Trocar units due to potential seal disengagement when mesh products are used incorrectly with the device. The issue could occur during surgical procedures.
Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.
Exactech is recalling 805 Equinoxe glenoid implant components due to nonconforming vacuum packaging that lacks required oxygen barrier protection, which could affect sterility.
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.
Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.
Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.
Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.
Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.
Exactech recalls 66,646 Equinoxe Reverse Shoulder humeral liners due to nonconforming packaging lacking required oxygen barrier protection. The missing EVOH layer means units do not meet established packaging specification.
Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.
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