FDA recall, , Moderate risk
ICU Medical Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray
Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray may have cracked syringe collars, leading to delayed or repeated blood draw or fluid leakage.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical Inc. of Minneapolis, Minnesota, recalled Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray because affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw or fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
The recall began December 19, 2025, and was added to the FDA's Enforcement Report on January 15, 2026. Distribution was in California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- UDI-DI
- 30351688073062
- 30351688006176
- 30351688029540
- 30351688039150
- 30351688081173
- Lot code
- 6141992
- 6156228
- 4080P-2
- 6141999
- 6142000
- 6147906
- 4084P-1
- 6147907
- 4080PE
- 6131839
- 4080PG
- 6131838
- 6142001
- 6142002
Portex Spinal Tray, Item No. A3729-24 A3595
- UDI-DI
- 30351688075691
- 35019517108211
- Lot code
- 6146204
- A3595
- 6157980
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, Washington.
- Company
- ICU Medical Inc.Minneapolis, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98168
- Recall numbers
- Z-1100-2026 to Z-1101-2026
All recalls from ICU Medical Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
