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
21,444medical device recall records
2,151FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records
Records — page 96
21,444 detailed records are currently available in this category.
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.
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 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
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 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
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
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 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
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
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
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
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
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
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
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
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
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
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 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 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 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
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
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.
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.