Portex recallZ-1101-2026 · ICU Medical Inc. · initiated Dec 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On December 19. 2025, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that affected lots may have a crack present on the syringe collar. Customers were instructed to discontinue use of affected lots, and to destroy products following their institution's process for destruction. If destruction is not immediately possible, affected product should be quarantined until disposal.
Recall details
- Recall number
- Z-1101-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2025
- Posted by the FDA
- Jan 15, 2026
- Recalling firm
- ICU Medical Inc.
- Quantity
- 64290 total
- Product code
- CAZ
- FDA submissions
- K965017
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Product description
Portex Spinal Tray, Item No. A3729-24 A3595
Code information (models, lots, serial numbers)
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Portex A3595Icu Medical, Inc. · Anesthesia conduction kit1 recall0 reports
- Portex A3729-24Icu Medical, Inc. · Anesthesia conduction kit1 recall0 reports
Product lines
Other devices under the same FDA submission
85 devices cleared under K965017 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Portex NLD-15597-20Icu Medical, Inc. · Anesthesia conduction kit32 reports
- Portex 49661C-25Icu Medical, Inc. · Anesthesia conduction kit21 reports
- Portex NEPI-NLD-15545C-21Icu Medical, Inc. · Anesthesia conduction kit20 reports
- Portex 24-1300-22Icu Medical, Inc. · Anesthesia conduction kit15 reports
- Portex NEPI-NLD-15597C-20Icu Medical, Inc. · Anesthesia conduction kit11 reports
- Portex 24-1301-22Icu Medical, Inc. · Anesthesia conduction kit10 reports
- Portex NLD-15545C-21Icu Medical, Inc. · Anesthesia conduction kit10 reports
- Portex 49662-25Icu Medical, Inc. · Anesthesia conduction kit9 reports
- Portex NEPI-NLD-15597-20Icu Medical, Inc. · Anesthesia conduction kit8 reports
- Portex 24-1302-22Icu Medical, Inc. · Anesthesia conduction kit7 reports
- Portex A4014-25Icu Medical, Inc. · Anesthesia conduction kit7 reports
- Portex A4209-22Icu Medical, Inc. · Anesthesia conduction kit7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98168).
- Z-1100-2026 · Open, ClassifiedPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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