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.
Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.
Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.
Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.
Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.
Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.
Medline Industries is recalling 1,512 Convenience Kits nationwide that contain Lidocaine HCL Injection USP ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.
Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection.
Bard Access Systems is recalling soft tissue biopsy trays (models 4380 Economy and 4382A) due to lidocaine ampoules being manufactured under deficient manufacturing practices.
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.
Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.
Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.
Dexcom is recalling two lots of G7 glucose sensors that were stolen during destruction and sold through unauthorized channels. These sensors were designated for destruction due to improper sterilization, increased infection risk, and potential for inaccurate or missing readings.
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