Spinal tray syringes recalled over a crack on the syringe collar
ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a cracked collar may cause blood leakage and repeated procedures, and no injuries are reported.
Plain-English summary
The Portex Spinal Tray, item numbers A3729-24 and A3595, is being recalled by ICU Medical Inc.
Affected lots of syringes may have a crack on the syringe collar, which the firm states may lead to delayed or repeated blood draw or fluid delivery. The record adds that the issue may also lead to blood leakage during sampling of arterial blood, or leakage during fluid delivery.
The record lists 64,290 units in total, with UDI-DI 30351688075691 for A3729-24 and the lot details recorded in the enforcement record. Distribution was nationwide in the United States, in California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Washington. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- Portex Spinal Tray, Item No. A3729-24 A3595
- Manufacturer
- ICU Medical Inc.
- Category
- Medical Device — Spinal tray
- Affected units
- 64,290
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26
- removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Distribution
Part of a larger recall action
This product is one of 2 recalled by ICU Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Same hazard · cracked collar
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