ICU Medical, Inc. recalls Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not…
Read the official notice →- Date
- 2026-09-23
- Country
- United States
- Brand
- ICU Medical
- Product
- Oncology sets with drip chambers
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states and territories…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ICU Medical recalls
- 2026-09-23
USICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24…
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN,…Official notice →- 2026-07-29
- US
ICU Medical Inc. recalls Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's…
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- 2026-07-22
- US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2026-06-17
- US
ICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA,…Official notice → - 2026-05-27
- US
ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer…
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy…
FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX,…Official notice → - 2026-01-28
- US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Philippines.Official notice →
Other drugs & medical recalls in the United States
- 2026-09-23
- US
GE Healthcare recalls Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient…
- US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- US
Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2,…
Due to a software issue
FDA · DeviceNuclein LLCUS Nationwide distribution in the states of Alabama, Delaware, Florida,…Official notice → - US
AVID Medical, Inc. recalls Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
FDA · DeviceAbiomed, Inc.Domestic: Nationwide Distribution. International: United Arab Emirates,…Official notice → - US
Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.