ICU Medical, Inc.: 640 FDA recall reports
Every medical device recall the FDA has published for ICU Medical, Inc.. The fault, and how the agency graded it.
640Reports
22Class I
123Ongoing
2026-07-29Most recent
22 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver the
Z-2759-2026 · Class II · reported 2026-07-29 · Ongoing
- Why it was recalled
- ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- Product
- Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 39,750 units
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion
Z-2723-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Product
- ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 12525 units
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Z-2724-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Product
- ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 5059 units
Plum Duo Precision IV Pump, 40002-0403
Z-2313-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- Product
- Plum Duo Precision IV Pump, 40002-0403
- Where it went
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- How much
- 13,613
Plum Duo Infusion Pump, 40002-0401
Z-2312-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- Product
- Plum Duo Infusion Pump, 40002-0401
- Where it went
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- How much
- 13,613
Plum Solo Precision IV Pump, 40001-0401
Z-2311-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- Product
- Plum Solo Precision IV Pump, 40001-0401
- Where it went
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- How much
- 13,613
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;
Z-2210-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- Product
- Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
- Where it went
- US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.
- How much
- 20,506
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Z-1118-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Product
- ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- Where it went
- Worldwide distribution - US Nationwide and the country of Philippines.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Z-1111-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
- Product
- Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Where it went
- Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.
- How much
- 14,684,607 items
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Z-1120-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Product
- ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
- Where it went
- Worldwide distribution - US Nationwide and the country of Philippines.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Z-1119-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Product
- ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
- Where it went
- Worldwide distribution - US Nationwide and the country of Philippines.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Z-1100-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- Product
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Where it went
- US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
- How much
- 64290 total
Portex Spinal Tray, Item No. A3729-24 A3595
Z-1101-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- Product
- Portex Spinal Tray, Item No. A3729-24 A3595
- Where it went
- US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
- How much
- 64290 total
Plum Duo Infusion System, List Number 40002-04-01
Z-1094-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
- Product
- Plum Duo Infusion System, List Number 40002-04-01
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 423 units
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003
Z-0965-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
- Product
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Where it went
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- How much
- 7 customers
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-
Z-0966-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Where it went
- US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
- How much
- 12 customers
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Z-0348-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
- Where it went
- 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.
- How much
- 8475 units
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Z-0357-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
- Where it went
- 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.
- How much
- 2000 units
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Z-0330-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
- Where it went
- 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.
- How much
- 2000 units
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Z-0364-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemosafeLock Connecter REF: KL-FNU3
- Where it went
- 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.
- How much
- 134,700 units
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Z-0356-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
- Where it went
- 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.
- How much
- 900 units
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Z-0354-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
- Where it went
- 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.
- How much
- 80 units
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Z-0329-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
- Where it went
- 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.
- How much
- 2100 units
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Z-0351-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
- Where it went
- 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.
- How much
- 950 units
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Z-0353-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
- Where it went
- 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.
- How much
- 6450 units
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger,
Z-0332-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU 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
- Where it went
- 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.
- How much
- 11000 units
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA32
Z-0365-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- Where it went
- 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.
- How much
- 202900 units
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4
Z-0337-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
- Where it went
- 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.
- How much
- 600 units
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w
Z-0333-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU 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
- Where it went
- 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.
- How much
- 7950 units
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Z-0347-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Product
- ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
- Where it went
- 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.
- How much
- 53,050 units
Showing the 30 most recent of 640. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls