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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 Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.
Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.
Medical device products from Family Dollar stores in six Southern states are being recalled due to potential rodent activity at a distribution center. Affected items include feminine hygiene products, surgical masks, contact lens solutions, and bandages.
Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.
Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.
Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.
Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.
Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.
Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.
Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL (Model CS203-EN, Lot Y060321-09) with defective dressing containing holes that prevent creating an occlusive seal for chest wounds.
Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.
Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.
Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.
Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.
Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.
Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
Boston Scientific is recalling 7,115 units of JAGTOME REVOLUTION RX devices worldwide due to sterile barrier breach that could allow contamination.
Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.
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