Medical DeviceNov 5, 2025
Cepheid Xpert SA Nasal Complete recall — FDA Z-0414-2026
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class IIFDA: OngoingCepheid
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 27
Records are ordered by the best available source date.
Medical DeviceNov 5, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 recall — FDA Z-0408-2026
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection…
Class IIFDA: OngoingGreiner Bio-One North America, Inc.
Medical DeviceNov 5, 2025
IMPRIS Imaging IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI recall — FDA Z-0163-2026
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Class IFDA: OngoingIMPRIS Imaging Inc.
Medical DeviceNov 5, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock recall — FDA Z-0340-2026
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" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating recall — FDA Z-0361-2026
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 13mm Closed Vial Spike REF: CL-82 recall — FDA Z-0349-2026
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 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall — FDA Z-0359-2026
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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating recall — FDA Z-0358-2026
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 Navigation Advanced Platform Patient Engagement (PE SNAP), software version recall — FDA Z-0321-2026
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
MicroSurgical Technology MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic recall — FDA Z-0411-2026
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Class IIFDA: OngoingMicroSurgical Technology Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall — FDA Z-0346-2026
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
CareFusion 303 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 recall — FDA Z-0369-2026
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
Dexcom G6 and G6 Pro Android US CGM App recall — FDA Z-0318-2026
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts…
Class IFDA: OngoingDexcom, Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 recall — FDA Z-0336-2026
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 Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging recall — FDA Z-0320-2026
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
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0306-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10 recall — FDA Z-0341-2026
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
PHILIPS MEDICAL SYSTEMS Model: Incisive CT recall — FDA Z-0375-2026
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
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon recall — FDA Z-0338-2026
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 ChemosafeLock Bag Spike REF: KL-BS001U3 recall — FDA Z-0363-2026
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
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0307-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 recall — FDA Z-0342-2026
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 Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port recall — FDA Z-0362-2026
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 Port REF: CL2100 recall — FDA Z-0350-2026
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.