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ICU Medical, Inc. recall records

96 reported ongoing

96 records in this archive. Latest source date Aug 20, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

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

Class IIReported 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 an...

Official source
FDA device enforcement

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

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

Class IIReported 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 an...

Official source

Reasons in these listed records

  • Port weld of drug transfer device may separate or break during use and potentially result in a leak.

These examples come from this result page and are not a ranking of every recall reason.

Checking ICU Medical, Inc.

Is there a recall on icu medical, inc. right now?

This archive contains 96 records, including 96 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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