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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.
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.
Synthes (USA) Products LLC is recalling 4 units of sterile titanium trochanteric fixation nails because the locking mechanism and protective cap were missing.
Avid Medical is recalling 330 QA Packs because the included swab stick expires before the kit's expiration date.
Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.
B. Braun Medical is recalling 460 Pain Management Trays containing 22GA SafetyGlide Needles due to the presence of loose polypropylene foreign matter.
Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.
Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.
Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.
Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.
B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.
Sage Products Inc. is recalling Toothette Oral Care Q Care & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling 120 units of Customer Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.
Synthes USA is recalling 239 units of Norian Drillable Inject because kit expiration dates do not align with the earliest expiration dates of the component lots.
Sage Products is recalling Q Care Oral Cleansing & Suctioning System kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.
Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.
Aesculap Implant Systems LLC is recalling 292 units of the JS Series SterilContainer S2 System because they were released to the market before receiving authorized FDA 510K clearance.
B. Braun Medical is recalling 300 Contiplex Nerve Block Trays because they contain needles with loose polypropylene foreign matter above release specifications.
AMEDA is recalling specific lots of Purely Yours Breast Pumps because they were manufactured with a UK power adapter instead of the correct one.
Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Philips is recalling 71 HeartStart MRx defibrillators because a defective component may prevent shock delivery in AED mode.
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