ICU Medical Inc. Portex Spinal Tray recall: Affected lots of syringes may have a crack on the syringe collar
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.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: 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.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-1101-2026
- Published
- January 21, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical Inc.
- Product type
- Medical devices
- Units affected
- 64290 total
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
- UPC codes
- 30351688075691, 35019517108211
Products covered by this recall
Portex Spinal Tray, Item No. A3729-24 A3595
Check your product
The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 30351688075691
- 35019517108211
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 6146204
- 6157980 — 64290 total
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
ICU Medical Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: ICU Medical Inc. — 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical Inc. medical devices 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. 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.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 30351688075691, 35019517108211; lot code 6146204, 6157980 — 64290 total. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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