Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published June 3, 2025

ICU Medical SwabCap Disinfecting Caps May Not Disinfect Properly

ICU Medical recalls SwabCap disinfecting caps for needle-free connectors due to potential incomplete seals causing alcohol evaporation and inadequate disinfection. Affected products include SwabSleeve and 200-count boxes with specific reference numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2116-2025Medical deviceICU Medical ›
Take action

Contact the company

Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
✎ GovInfoNow plain-language explainer

ICU Medical is recalling SwabCap disinfecting caps for needle-free connectors because a manufacturing issue may cause the cap to have an incomplete seal. This could lead to isopropyl alcohol evaporating from the sponge, resulting in inadequate disinfection of medical connectors. Read more at govinfonow.com/recall/52158-icu-medical-swabcap-disinfecting-caps-may-not-disinfect-properly.

Source Summary by GovInfoNow · govinfonow.com/recall/52158-icu-medical-swabcap-disinfecting-caps-may-not-disinfect-properly · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2116-2025

Cite this page

“ICU Medical SwabCap Disinfecting Caps May Not Disinfect Properly.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52158-icu-medical-swabcap-disinfecting-caps-may-not-disinfect-properly. Based on FDA recall #Z-2116-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2116-2025%22&limit=1).

The FDA announced on June 3, 2025, that ICU Medical is recalling SwabCap Disinfecting Caps for needle-free connectors due to a manufacturing issue that may result in inadequate disinfection. The agency issued recall number Z-2116-2025 for the voluntary Class II action affecting approximately 1.4 million units distributed worldwide.

How to tell if you have it

  • Brand: ICU Medical
  • Product: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000
  • Product: SwabCap, 200-ct. Box, REF: SCXT3-2000
  • Lot codes and expiration dates for REF SCXT3-5-2000: 14258739 (1-Dec-26), 14258743 (1-Feb-26), 14258744 (1-Dec-26), 14264200 (1-Dec-26), 14272241 (1-Dec-26), 14272248 (1-Dec-26), 14287456 (1-Dec-26), 14287459 (1-Dec-26), 14287480 (1-Dec-26), 14287482 (1-Dec-26), 14287485 (1-Dec-26), 14294832 (1-Dec-26), 14272254 (1-Dec-26), 14310313 (1-Dec-26), 14310425 (1-Dec-26), 14323354 (1-Dec-26), 14287475 (1-Dec-26), 14294840 (1-Dec-26), 14321645 (1-Jan-27), 14321652 (1-Jan-27), 14331169 (1-Jan-27), 14332773 (1-Jan-27), 14341732 (1-Oct-26), 14294825 (1-Jan-27), 14303209 (1-Jan-27), 14310308 (1-Jan-27), 14355404 (1-Jan-27), 14355409 (1-Jan-27)
  • Lot codes and expiration dates for REF SCXT3-2000: 14258214 (1-Jan-27), 14258206 (1-Jan-27), 14258208 (1-Feb-27)

The hazard

According to the FDA, a manufacturing issue may cause an incomplete seal between the foil lid and plastic container of the disinfecting caps. This defect can result in isopropyl alcohol evaporation from the sponge, which may lead to inadequate disinfection of needle-free connectors.

Context

GovInfoNow's records show ICU Medical has issued 60 other recalls since June 15, 2017. Recent brand recalls include a CADD Yellow Medication Cassette Reservoir recall on Aug. 20, 2026, due to leakage risk, and a Hotline Fluid Warming Set recall on June 24, 2026, also involving leakage. Other recent recalls of similar products include Medline Medical Kits Recall (Dec. 24, 2025), Medline Sterile Resuture Pack Kits Recall (Dec. 24, 2025), and Medline Convenience Kit recall (July 23, 2026).

How to tell if you have this one

Check for SwabSleeve (REF: SCXT3-5-2000) or SwabCap 200-count boxes (REF: SCXT3-2000). The reference numbers include specific expiration dates and lot numbers listed in the recall notice.

  • Brand
    ICU Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Reference

    Look for reference numbers SCXT3-5-2000 or SCXT3-2000 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 37 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Jun 3, 202512. FDA classified it Class II: Jul 11, 202523. Published in FDA’s Enforcement Report: Jul 23, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2116-2025 (June 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2116-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA