Medical DeviceSep 10, 2025
Visgeneer Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device recall — FDA Z-2501-2025
Due to products distributed without premarket clearance or approvals.
Class IIFDA: OngoingVisgeneer, Inc.
21,924medical device recall records
2,160FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records
Records — page 113
21,924 detailed records are currently available in this category.
Medical DeviceSep 10, 2025
900-00218 Sterile Cover 10-Pack Shipper Box Assembly recall — FDA Z-2519-2025
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the…
Class IIFDA: OngoingLumicell, Inc.
Medical DeviceSep 10, 2025
RAYSEARCH LABORATORIES AB RayStation with the following product descriptions: 1 recall — FDA Z-2492-2025
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 10, 2025
Boston Scientific WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010 recall — FDA Z-2431-2025
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceSep 10, 2025
RAYSEARCH LABORATORIES AB RayStation with the following product descriptions: 1 recall — FDA Z-2488-2025
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 10, 2025
Dexcom G7 CGM Android App recall — FDA Z-2446-2025
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System…
Class IFDA: OngoingDexcom, Inc.
Medical DeviceSep 10, 2025
MediHoney Paste recall — FDA Z-2505-2025
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class IIFDA: OngoingIntegra LifeSciences Corp. (NeuroSciences)
Medical DeviceSep 10, 2025
Medshape Universal Joints, REF: DNE-9000-UJ recall — FDA Z-2513-2025
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is…
Class IIFDA: OngoingMedshape, Inc.
Medical DeviceSep 10, 2025
Boston Scientific Neuromodulation Superion IDS Kit Superion Indirect Decompression System recall — FDA Z-2485-2025
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage…
Class IIFDA: OngoingBoston Scientific Neuromodulation Corporation
Medical DeviceSep 10, 2025
RAYSEARCH LABORATORIES AB RayStation with the following product descriptions: 1 recall — FDA Z-2491-2025
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 10, 2025
Boston Scientific WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) recall — FDA Z-2435-2025
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceSep 10, 2025
RAYSEARCH LABORATORIES AB RayStation with the following product descriptions: 1 recall — FDA Z-2489-2025
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and recall — FDA Z-2526-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
Medtronic MiniMed InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) recall — FDA Z-2496-2025
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to…
Class IIFDA: OngoingMedtronic MiniMed, Inc.
Medical DeviceSep 10, 2025
Baxter Healthcare Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall — FDA Z-2333-2025
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 10, 2025
Physio-Control LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 recall — FDA Z-2499-2025
Due to required inspections not being performed on products/units that have gone through servicing.
Class IIFDA: OngoingPhysio-Control, Inc.
Medical DeviceSep 10, 2025
Boston Scientific WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020 recall — FDA Z-2432-2025
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit recall — FDA Z-2527-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
Physio-Control LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 recall — FDA Z-2497-2025
Due to required inspections not being performed on products/units that have gone through servicing.
Class IIFDA: OngoingPhysio-Control, Inc.
Medical DeviceSep 10, 2025
Dexcom ONE+ Android CGM App recall — FDA Z-2449-2025
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System…
Class IFDA: OngoingDexcom, Inc.
Medical DeviceSep 10, 2025
CARIS LIFE SCIENCES MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI recall — FDA Z-2521-2025
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Class IIFDA: OngoingCARIS LIFE SCIENCES
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer recall — FDA Z-2523-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
CVS Honey Pad recall — FDA Z-2512-2025
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class IIFDA: OngoingIntegra LifeSciences Corp. (NeuroSciences)
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and recall — FDA Z-2525-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.