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Stop using now Medical device recall · FDA · Published September 8, 2025

ICU Medical ChemoLock Spike Recall: Port Weld Leak Risk

ICU Medical recalls ChemoLock Closed Vial Spikes with potential port weld leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.

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

🇺🇸 FDA recall #Z-0348-2026Medical deviceICU Medical ›
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Contact the company

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

ICU Medical is recalling ChemoLock Closed Vial Spikes that may leak due to a port weld issue. This could lead to medication leaks during use, posing a risk to patient safety. Read more at govinfonow.com/recall/51377-icu-medical-chemolock-spike-recall-port-weld-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51377-icu-medical-chemolock-spike-recall-port-weld-leak-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0348-2026

Cite this page

“ICU Medical ChemoLock Spike Recall: Port Weld Leak Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51377-icu-medical-chemolock-spike-recall-port-weld-leak-risk. Based on FDA recall #Z-0348-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0348-2026%22&limit=1).

ICU Medical, Inc. voluntarily recalled ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units (REF: CL-80S-5) due to a potential port weld separation that could cause a leak, the FDA announced on Sept. 8, 2025.

How to tell if you have it

  • Brand: ICU Medical
  • Product: ChemoLock Closed Vial Spike w/Skirt, 5 Units
  • REF: CL-80S-5
  • UDI: 10887709077116
  • Lot codes: 14395313, 14393195, 14396054
  • Units affected: 8,475

The hazard

The port weld of the drug transfer device may separate or break during use and potentially result in a leak.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent brand recalls include the Aug. 20, 2026 ICU Medical CADD Yellow Medication Cassette Reservoir Recall and the June 24, 2026 ICU Medical Hotline Fluid Warming Set Recall. Other recent recalls of similar products include the Oct. 17, 2025 Mozarc Medical Acute High Pressure Catheter Tray Recall and the June 15, 2026 Argon Medical Devices L-Cath Midline Catheter Recall.

How to tell if you have this one

Check for the model number CL-80S-5 and lot numbers 14395313, 143:93195, or 14396054. The product has a unique device identifier (UDI) starting with 10887709077116.

  • Brand
    ICU Medical
  • Category
    Medical device
FDA recall event · 38 products

All 38 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
Recall numberProduct, codes & lotsQuantity
Z-0328-2026ChemoLock Bag Spike, 01 units REF: CL-10-10; UDI:10887709071022/Lot: 14397202875 units
Z-0329-2026ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10; UDI:00887709070981/Lot: 143801092100 units
Z-0330-2026ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS; UDI:00887709094505/Lot: 144074002000 units
Z-0331-2026ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150; UDI:10887709094670/Lot: 14391937200 units
Z-0332-2026ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011; UDI:10887709057019/Lot: 1438605411000 units
Z-0333-2026ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511; UDI:10887709057026/Lot: 144006167950 units
Z-0334-2026ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929; UDI:10887709076768/Lot: 14400216, 144167691100 units
Z-0335-2026ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940; UDI:10887709095295/Lot: 144067733000 units
Z-0336-2026ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136; UDI:10887709096131/Lot: 14393176150 units
Z-0337-2026ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138; UDI:10887709096131/Lot: 14393176600 units
Z-0338-2026ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151; UDI:10887709098388/Lot: 14400230950 units
Z-0339-2026ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173; UDI:10887709123080/Lot: 14351926200 units
Z-0340-2026ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176; UDI:10887709123356/Lot: 14332784200 units
Z-0341-2026ICU Medical ChemoLock Bag Spike REF: CL-10; UDI:10887709056968/Lot: 144193307850 units
Z-0342-2026ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33; UDI:10840619061729/Lot: 14393155, 14400613, 143760514000 units
Z-0343-2026ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70; UDI:10887709057095/Lot: 14391971, 1439528916850 units
Z-0344-2026ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S; UDI:10887709067155/Lot:1437917611200 units
Z-0345-2026ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72; UDI:10887709062440/Lot:14385352, 144012509004 units
Z-0346-2026ICU Medical ChemoLock Closed Vial Spike REF: CL-80; UDI:10887709057125/Lot:143919766150 units
Z-0347-2026ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S; UDI:10887709069593/Lot:14379182, 14391979, 14395300, 14401254, 1438012153,050 units
Z-0348-2026ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5; UDI:10887709077116/Lot:14395313, 14393195, 143960548475 units
Z-0349-2026ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82; UDI:10887709085692/Lot:144074533350 units
Z-0350-2026ICU Medical ChemoLock Port REF: CL2100; UDI:10887709057002/Lot:14400191, 14379145133,255 units
Z-0351-2026ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360; UDI:10887709071398/Lot:14397348, 14377757950 units
Z-0352-2026ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900; UDI:10887709071411/Lot:143919541700 units
Z-0353-2026ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955; UDI:10887709071411/Lot:14386086 144074336450 units
Z-0354-2026ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20; Lot:14401659/ Distributed in France80 units
Z-0355-2026ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17; Lot:14385224; Distributed in Canada400 units
Z-0356-2026ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34; Lot:14400199; Distributed in Canada900 units
Z-0357-2026ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35; Lot:14407070,14384996,14391949; Distributed in Canada2000 units
Z-0358-2026ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950; Lot:14393168, 14414091; Distributed in Canada2450 units
Z-0359-2026ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951; Lot:14397353, 14418912; Distributed in Canada11000 units
Z-0360-2026ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967; Lot:14369083 14386090 14391965; Distributed in Canada5700 units
Z-0361-2026ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118; Lot:14393173, 14409213 ; Distributed in Canada1600 units
Z-0362-2026ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188; Lot:14369087 ; Distributed in Canada200 units
Z-0363-2026ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3; Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan134700 units
Z-0364-2026ICU Medical ChemosafeLock Connecter REF: KL-FNU3; Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan134,700 units
Z-0365-2026ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3; Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; Distributed in Japan202900 units
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the ChemoLock Closed Vial Spikes with the specified lot numbers and UDI to prevent potential leaks.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth 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: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: 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: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wyoming.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Sep 8, 202512. FDA classified it Class II: Oct 27, 202523. Published in FDA’s Enforcement Report: Nov 5, 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.

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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-0348-2026 (September 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0348-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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