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 recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing a risk to patient health.
Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.
Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.
Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.
Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 diagnostic test kits due to positive measurement bias in some samples. The affected kits may report falsely elevated test results, particularly around the normal limit of 35 U/mL.
Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.
Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.
Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.
Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in the US, Canada, and Panama.
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
Medline Industries recalls esophagectomy convenience kits containing plastic syringes with leaks and breakage issues. The defects may pose a risk to patient health during surgical procedures.
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