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.
Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Excelsior Medical is recalling sterile triple lead tubing sets because a molding defect may allow fluid leaks or air entry during use.
Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.
Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.
Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.
Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.
Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.
Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.
Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.
Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.
Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.
Dental EZ Group is recalling 45 Titan T 5K dental motors because the housing was incorrectly laser marked as a 20K motor.
Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.
Remel Inc. is recalling specific lots of Thermo Scientific VersaTREK REDOX 1 in vitro diagnostic products because they failed to provide positive signals for Streptococcus pneumoniae.
Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers because a sterility expiration date was misprinted as '2016-16' instead of '2016-06'.
Zimmer, Inc. is voluntarily recalling a specific lot of dental implants due to a potential crack in the outer vial cap.
Innovasis is recalling 32 units of Excella II Standard Pedicle Screws because the size and catalog number are mislabeled.
Siemens Medical Solutions is updating syngo RT Dosimetrist 2.7 software to fix a safety issue where structure names were not stored correctly.
Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.
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