Medical DeviceNov 5, 2025
Mega Ballast recall — FDA Z-0188-2026
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Class IFDA: OngoingBALT USA, LLC
Monthly breakdown
2025 recalls by month
Select a month to review the recall records reported during that period.
December 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categoriesSeptember 2025285 records · 4 categoriesAugust 2025239 records · 4 categoriesJuly 2025370 records · 4 categoriesJune 2025342 records · 4 categoriesMay 2025258 records · 4 categoriesApril 2025302 records · 4 categoriesMarch 2025259 records · 4 categoriesFebruary 2025260 records · 4 categoriesJanuary 2025354 records · 4 categories
2025 recalls — page 28
Records are ordered by the best available source date.
Medical DeviceNov 5, 2025
ASP Global, LLC. dba Anatomy Supply Partners SAFE-T-FILL Micro Capillary Blood Collection recall — FDA Z-0372-2026
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare…
Class IIFDA: OngoingASP Global, LLC. dba Anatomy Supply Partners, LLC.
Medical DeviceNov 5, 2025
CareFusion 303 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 recall — FDA Z-0368-2026
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceNov 5, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 recall — FDA Z-0331-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 recall — FDA Z-0352-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S recall — FDA Z-0347-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Medistim MiraQ System recall — FDA Z-0410-2026
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support…
Class IIFDA: OngoingMedistim Asa
Medical DeviceNov 5, 2025
AESCULAP REDUCING CONVERTER 10/12MM TO 5MM recall — FDA Z-0312-2026
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceNov 5, 2025
Surgical Theater SpineAR Surgical Navigation Advanced Platform Patient Engagement recall — FDA Z-0324-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip recall — FDA Z-0333-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Surgical Theater Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP) recall — FDA Z-0323-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port recall — FDA Z-0337-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Trividia Health Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter recall — FDA Z-0413-2026
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment…
Class IIFDA: OngoingTrividia Health, Inc.
Medical DeviceNov 5, 2025
Aesculap SEALING UNIT F/10/12MM TROCARS W.REDUCER recall — FDA Z-0309-2026
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceNov 5, 2025
Beckman Coulter CellMek SPS Sample Preparation System, REF: C44603 recall — FDA Z-0412-2026
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceNov 5, 2025
PHILIPS MEDICAL SYSTEMS Model: CT 5300; Product Code (REF): 728285; Software Versions recall — FDA Z-0376-2026
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS
Medical DeviceNov 5, 2025
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality recall — FDA Z-0325-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system recall — FDA Z-0319-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 recall — FDA Z-0365-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall — FDA Z-0332-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 recall — FDA Z-0353-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 recall — FDA Z-0351-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 recall — FDA Z-0329-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 recall — FDA Z-0354-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
About the 2025 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.