Class I U.S. Food and Drug Administration

Cook Incorporated Beacon Tip Centimeter Sizing Catheter RPN/GPN recall: Marker bands may be at an increased risk of cracking/breakage. Potential

Recall published 6 months ago

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1936-2026
Published
May 13, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cook Incorporated
Product type
Medical devices
Units affected
4,245
Distribution
Nationwide
Made in
United States
Lot / code info
G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots 16886459 16874181 16855513 16867505 16815763 16796665 16802282 16766437 16734169 16695772 G31216 UDI-DI 00827002312166 Lots 16886460 16891299 16912494 16831676 16836358 16836359 16836360 16864534 16864652 16881655 16882508 16912493 16872559 16878260 16824312 16831675 16874182 16855514 16868889 16859732 16858079 16878261 16806270 16804619 16805454 16804399 16815762 16803920 16803921 16802096 16802097 16814369 16814370 16806333 16804620 16831528 16822289 16822290 16782945 16782946 16795733 16796300 16779437 16795734 16800424 16802632 16824313 16764526 16763024 16800730 16802633 16802133 16800731 16821105 16824314 16711110 16717839 16730326 16720153 16736740 16739291 16693653 16690051 16673569 16680240 16704378 G31220 UDI-DI 00827002312203 Lots 16881657 16872241 16827163 16852999 16805455 16804400 16802132 16779438 16730325 16739292 16700199 16690050 16661312 16674400 G31221 UDI-DI 00827002312210 Lots 16839296 16879977 16814371 16821104
UPC codes
00827002312135, 00827002312142, 00827002312166, 00827002312203, 00827002312210

Products covered by this recall

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

Check your product

The notice names 6 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.

  • 00827002312135
  • 00827002312142
  • 00827002312166
  • 00827002312203
  • 00827002312210

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 245

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 Sterility

Cook Incorporated — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Cook Incorporated — 750 N Daniels Way, Bloomington, IN, 47404-9120

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 Cook Incorporated medical devices recalled?

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00827002312135, 00827002312142, 00827002312166; lot code 245. 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?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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