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 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.
Biomet is recalling TRAUMA A.L.P.S. fibula composite locking plates due to packaging that may not maintain sterile barrier integrity, posing a risk of infection if used.
BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.
Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.
Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.
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.
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.
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.
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 RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.
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 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
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.
GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.
Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.
Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.
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 is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.
Bard Peripheral Vascular Inc. is recalling 2,880 Atraumatic Adult Lumbar Puncture Trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally.
Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.
Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.
Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.
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 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.
Looking for a different category? Browse all recalls.