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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.
Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.
Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Riverpoint Medical is recalling 2,499 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.
Riverpoint Medical is recalling 1,222 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, which could compromise the sterile field and increase the risk of surgical site infection.
FDA is recalling specific Covidien surgical stapler kits because the staples may not form properly, potentially preventing adequate hemostasis during surgery.
Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise the sterile field and increase the risk of surgical site infection.
Riverpoint Medical is recalling 1,886 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.
North American Rescue LLC is recalling 4 In. Flat Responder Emergency Trauma Dressings because they may lack sterility assurance. The affected dressings are packaged in various first aid and trauma kits.
Ameditech is recalling QuickTox Drug Screen DipCards because immunoassay enzymes failed performance tests, meaning the products may not consistently detect all compounds at labeled levels.
FDA is recalling Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.
Ameditech is recalling Alere iScreen Multi Drug Detection tests because they may fail to consistently detect all compounds at labeled levels.
Riverpoint Medical is recalling 1,260 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.
Riverpoint Medical is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.
Ameditech Inc is recalling various CLIA Waived Rapid Drug Tests because immunoassay enzymes failed performance standards, preventing consistent detection of compounds.
Riverpoint Medical is recalling 8,598 units of non-sterile Velosorb sutures because use could compromise the sterile field and increase the risk of surgical site infection.
Riverpoint Medical is recalling 7,969 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.
FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Riverpoint Medical is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.
Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise the sterile field and increase the risk of surgical site infection.
Riverpoint Medical is recalling 1,236 units of non-sterile Velosorb sutures due to risks of surgical site infection and compromised sterile fields.
Riverpoint Medical is recalling 7,496 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.
Riverpoint Medical is recalling 3,109 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.
ev3 Inc. is recalling Pacific Xtreme balloon dilation catheters due to a labeling discrepancy regarding the Rated Burst Pressure value.
Ameditech is recalling Noble 1 Step+ Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
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