CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Portex Spinal Tray recalled by ICU Medical

ICU Medical is recalling Portex Spinal Tray, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

Quantity recalled64290 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1101-2026
FDA event ID: 98168
Recalling firm: ICU Medical, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2025
FDA classified: 15 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Spinal Implants

Timeline

19 Dec 2025	Recall initiated by company
15 Jan 2026	Classified by FDA	+27 days
21 Jan 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Portex Spinal Tray, Item No. A3729-24 A3595

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

Nationwide California Florida Illinois Indiana Massachusetts Michigan Minnesota Missouri Nebraska New Jersey New York Ohio Oklahoma Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98168

This product is part of a recall event; the main page for the event is Pulsator Arterial Blood Sampling Kit recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026	CLASS II	Pulsator Arterial Blood Sampling Kit recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide

More recalls from ICU Medical

All 663

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

Other Spinal Implants recalls

All 1,159

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