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…
Read the official notice →- Date
- 2026-05-27
- Country
- United States
- Brand
- ICU Medical
- Product
- Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-29
USICU 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 → - 2026-01-28
- 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 → - US
ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear;…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of FL, AZ, RI,…Official notice → - 2026-01-21
- US
ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage…
FDA · DeviceICU Medical Inc.US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO,…Official notice →
Other drugs & medical recalls in the United States
- 2026-05-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and…
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice → - US
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Novapproach Spine, LLC recalls OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique,…
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay…
FDA · DeviceNovapproach Spine, LLCUS Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.Official notice → - US
TANGENT ENDOSCOPY, LLC recalls Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
FDA · DeviceTANGENT ENDOSCOPY, LLCUS Nationwide distribution in the states of North Carolina, Arizona, and Nevada.Official notice → - US
Becton, Dickinson and Company recalls Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
FDA · DeviceBecton, Dickinson and CompanyWorldwide - US Nationwide distribution including in the states of TX, SC, CT,…Official notice → - US
Wisconsin Pharmacal Company recalls MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1…
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.