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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.
Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.
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.
A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.
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.
Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and other quality issues. The defects were identified in an FDA Safety Alert and may pose a risk to patient health.
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.
Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.
Medline is recalling spinal block syringes due to leaks, breakage, and other quality issues identified in an FDA safety alert. The recalled lots have worldwide distribution and span from 2019 to 2023.
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
Medline is recalling multiple convenience kits containing defective plastic syringes that may leak or break, posing potential patient health risks. The defective syringes were identified through an FDA Safety Alert issued March 19, 2024.
Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.
Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.
FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.
Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.
Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.
Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.
Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.
Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.
Medline is recalling nerve block convenience kits for defective plastic syringes that may leak or break, creating a patient safety risk during medical procedures.
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