ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…
Read the official notice →- Date
- 2025-07-23
- Country
- United States
- Brand
- ICU Medical
- Product
- SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-29
USICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set…
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or…
FDA · DeviceICU Medical, Inc.Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign)…Official notice →- 2025-09-10
- US
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- 2025-08-13
- US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- 2025-06-25
- US
ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA,…Official notice → - 2025-05-21
- US
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA,…Official notice → - 2025-03-19
- US
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045,…
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Other drugs & medical recalls in the United States
- 2025-07-23
- US
Microbiologics Inc recalls KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
FDA · DeviceMicrobiologics IncUS distribution to states of: Utah and Ohio; and OUS (International) to…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806…
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution;…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD,…Official notice → - US
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description:…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
FDA · DeviceWaismed Ltd.Worldwide distribution: US (nationwide) to state of: NC and OUS…Official notice → - US
Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a…
FDA · DeviceBeckman Coulter, Inc.International distribution to the country of Andorra, Bulgaria, Denmark,…Official notice → - US
NeuroSync, Inc. recalls NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android…
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
FDA · DeviceNeuroSync, Inc.United States Nationwide distribution in the states of New York (NY), Texas…Official notice → - US
Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not…