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.
Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
A handheld ultraviolet-C germicidal wand is recalled because it emits an unsafe level of UVC radiation, reaching the Risk Group 3 exposure limit in about 2.2 minutes and risking skin and eye injuries.
Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.
UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
MEDITECH Expanse Laboratory modules are recalled because entering multiple keys that trigger input simultaneously may remove data from the first field of screens or questionnaires. 148 units are affected.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.
Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.
TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
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