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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.
Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.
The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.
Bard Peripheral Vascular is recalling 116,770 adult lumbar puncture trays due to manometer leaks and connector mating defects that could affect procedure performance.
Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.
Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.
Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.
Hill-Rom Traverse Rail Carrier E-System components contain non-conforming screws that are too short to secure the rail properly. The screws could loosen over time, causing the rail system to fall and potentially injure caregivers or patients.
Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.
LivaNova is recalling four Sorin Centrifugal Pump CP5 Drive Units because a ferrite ring on the power cable may be missing. The units were distributed in Florida, Texas, and Nebraska.
Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.
Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.
CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.
CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.
CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct instructions.
CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.
CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.
Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.
Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
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