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U.S. Department of Health and Human Services

Class 2 Device Recall Portex Spinal Tray

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 Class 2 Device Recall Portex Spinal Traysee related information
Date Initiated by FirmDecember 19, 2025
Date PostedJanuary 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1101-2026
Recall Event ID 98168
510(K)NumberK965017 
Product Classification Anesthesia conduction kit - Product Code CAZ
ProductPortex Spinal Tray, Item No. A3729-24 A3595
Code Information 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Recalling Firm/
Manufacturer		 ICU Medical Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactCustomer Service
800-258-5361
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce64290 total
DistributionUS Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CAZ
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