Cook Beacon Tip Centimeter Sizing Catheter Recall
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Cook Incorporated is recalling 4,245 Beacon Tip Centimeter Sizing Catheters due to risk of marker band cracking or breakage, which may lead to life-threatening harm.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 27, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Cook Incorporated is recalling certain Beacon Tip Centimeter Sizing Catheters because the marker bands may be at an increased risk of cracking/breakage. Potential adverse events 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. This is a Class I recall.
Which Products Are Affected
The recall affects 4,245 units of Beacon Tip Centimeter Sizing Catheter distributed nationwide in the US and to Brunei, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, and Uruguay. Affected models include:
- NR5.0-35-70-P-10S-0-CSC-20 (G31213, UDI-DI 00827002312135, Lot 16805456)
- NR5.0-35-100-P-10S-0-CSC-20 (G31214, UDI-DI 00827002312142, multiple lots)
- NR5.0-35-100-P-10S-PIG-CSC-20 (G31216, UDI-DI 00827002312166, multiple lots)
- NR5.0-35-70-P-10S-VCF-CSC-20 (G31220, UDI-DI 00827002312203, multiple lots)
- NR5.0-35-100-P-10S-VCF-CSC-20 (G31221, UDI-DI 00827002312210, multiple lots)
Recall number: Z-1936-2026. Recall initiation date: April 2, 2026.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter for returns or further information. Contact Cook Incorporated for assistance with affected products.
Why This Matters
The Class I recall involves a device used in angiographic procedures where marker band failure could result in serious injury or death.
Source
FDA recall event ID 98682, recall number Z-1936-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,648 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.