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.
Philips is recalling the Allura Xper FD20/15 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.
Oxoid, part of Thermo Fisher Scientific, is recalling one lot of the Microbact 12L Listeria identification kit because it may identify the incorrect organism.
Philips is recalling the Azurion 3 M15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medline is recalling the Airway Exam Kit because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling six bronchoscopy and thoracic kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.
BD is recalling the Kiestra ReadA because after a system reboot one or more modules may become unreachable via the remote connectivity interface, delaying plate retrieval.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Navajo Manufacturing is recalling the Handy Solutions Neck & Shoulders Heating Pad because folding it during use raises power density in the folded area, causing excessive temperatures the limit device cannot sense.
Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.
Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Merit Medical is recalling ProGuide Chronic Dialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
I.T.S. GmbH is recalling the Pelvic Reconstruction System PRS RX and PRS Phoenix because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
Olympus is recalling the OER-Elite Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.
I.T.S. GmbH is recalling the I.T.S. Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
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