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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2381–2400 of 39,430 recalls

Class IIOngoing

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

Beckman Coulter, Inc.

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemoLock Port REF: CL2100

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical ChemoLock Bag Spike REF: CL-10

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →
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