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MEDICAL DEVICE RECALLCRITICAL
Beacon Tip Centimeter Sizing Catheter
Cook recalls Beacon Tip Centimeter Sizing Catheters due to risk of marker band cracking and device fragmentation.
What to do
Do not use the affected catheters. Return unused devices to Cook Incorporated for replacement or credit.
Why it was recalled
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because the marker bands may crack or break during use, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 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). | 00827002473089, 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, 16713191 | Z-1935-2026 |
| 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). | 00827002312135, 16805456, 00827002312142, 16886459, 16874181, 16855513, 16867505, 16815763, 16796665, 16802282, 16766437, 16734169, 16695772, 00827002312166, 16886460, 16891299, 16912494, 16831676, 16836358, 16836359 | Z-1936-2026 |
| Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience. | 00827002119161, 16905390, 16888263, 16905391, 16909577, 16918137, 16924645, 16924646, 16928311, 16928312, 16928313, 16947353, 16899656, 16899655, 16894976, 16879299, 16890985, 16903201, 16885859, 16890986 | Z-1934-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Cook Incorporated
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification