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.
Sunrise Medical is recalling Quickie Q7 wheelchairs because the backrest bracket can fracture, causing the backrest to detach from the chair frame.
Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.
Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.
The Metrix Company is recalling container fill and transfer sets because they cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling 16 AUTOCOMP6 XPS High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.
The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling 93 AUTOCOMP6 XP High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
Integra LifeSciences Corp. is recalling 27 units of the External Fixation System Rocker Bottom because the embedded silicone insert may become dislodged or loose.
Zimmer GmbH is recalling two Avenir Moller hip stem models due to a packaging mix-up that could lead to the use of the incorrect implant.
Beckman Coulter is recalling Allegra X-5 rotor yokes because a defect allows improper rotor seating, which could lead to rotor failure if buckets are loaded in an imbalanced configuration.
Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.
The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.
LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.
Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.
The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.
LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.
Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.
Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.
Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.
LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
The Metrix Company is recalling 323 AUTOCOMP6 High Speed Compounders because the devices cannot meet designed accuracy specifications when dispensing into bags.
LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.
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