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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.
Philips is recalling Intera Achieva 1.5T Pulsar MRI systems because ceiling speakers may fall due to magnetic attraction.
Alcon is recalling LuxOr E71 and E71 Q-Vue ophthalmic microscopes because the optical head may detach from the stand due to missing thread adhesive.
Philips is recalling 11,226 MR-OR 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Achieva XR MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Zimmer Biomet is recalling 45 Vanguard Knee System patella components because a potential commingle may cause the implant size to not match the label.
The FDA issued recall Z-0969-2019 for Draco Enzymatic Deep-Cleaning Pads because they were found contaminated with Pseudomonas bacteria.
Siemens Medical Solutions is recalling one Sensis Vibe System unit due to a software error that may cause system crashes during clinical procedures.
Zimmer Biomet is recalling 90 Vanguard Knee System patella implants because a potential commingle could result in the implant size not matching the label.
Becton Dickinson is recalling Phoenix AST-s Indicator lots because they cause increased test aborts. The products were distributed to 41 US states and 33 foreign countries.
Cook Inc. is recalling 797 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding the retention mechanism.
Shimadzu Medical Systems is recalling eight BRANSIST safire digital angiography systems due to a software error that can cause abnormal termination during initial patient registration.
Cook Inc. is recalling 975 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding down the retention mechanism.
Terumo Cardiovascular Systems Corporation is recalling 12 packs of Cardiovascular Procedure Kits because the presence of natural rubber latex is not declared on the label.
Becton Dickinson is recalling Phoenix AP AST Indicator Bags because certain lots cause increased test aborts. The products were distributed to 40 US states and 33 foreign countries.
Abbott Vascular is recalling 26 units of the PLUS 30 Priority Pack Accessory Kit because an incorrect expiration date was entered for one lot.
Becton Dickinson is recalling Phoenix AST Indicator lots because panels show increased test aborts. The recall covers 62,880 units distributed in the US and 33 foreign countries.
BrosMed Medical Co., Ltd. is recalling 400 Hermes NC PTA Balloon Dilatation Catheters because the labels display incorrect, higher-rated burst pressure information.
Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.
Philips is recalling 57 PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing a risk of injury to patients and users.
Baxter Healthcare is recalling 1,085 Kaguya Automated Peritoneal Dialysis Systems because a software defect may cause shortened dwell times during therapy.
Philips is recalling PageWriter TC50 electrocardiogram devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.
Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC20 devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury.
Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
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