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…
Read the official notice →- Date
- 2025-05-21
- Country
- United States
- Brand
- ICU Medical
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-08-13
USICU 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.
- 2025-07-23
- US
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…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice → - 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 → - 2025-03-19
- 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
- US
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling…
- 2024-12-18
- US
ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The…
Due to finished goods incorrectly packaged and labeled.
FDA · DeviceICU Medical, Inc.Worldwide - U.S. Nationwide distribution in the state of IL and the country of…Official notice →
Other drugs & medical recalls in the United States
- 2025-05-21
- US
Klinika Mdical Gmb recalls KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device…
Potential for microbial contamination.
FDA · DeviceKlinika Mdical GmbUS Nationwide distribution in the state of Massachusetts.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Three is the potential for the retractors to puncture through the sterile packaging.
- US
Contec Medical Systems Co., Ltd. recalls CMS8000 Patient Monitor
Patient monitor has nine identified cybersecurity vulnerabilities.
FDA · DeviceContec Medical Systems Co., Ltd.US Nationwide distribution in the states of CA, IL, FL, KY, TX.Official notice → - US
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular…
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- US
Augmedics Ltd. recalls Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation…
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
- US
Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.