FDA Medical devices recall ·
Portex Spinal Tray, Item No recall
- Recall number
- Z-1101-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- ICU Medical, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 64290 total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Portex Spinal Tray, Item No. A3729-24 A3595
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
States: California Florida Illinois Indiana Massachusetts Michigan Minnesota Missouri Nebraska New Jersey New York Ohio Oklahoma Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1101-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.