Fresh Recalls

Aurous Centimeter Sizing Catheter RPN N5: recall status

Notice names this product. Cook Incorporated’s Aurous Centimeter Sizing Catheter RPN N5 is named in FDA Class I recall Z-1935-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191. Units affected: 271. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Aurous Centimeter Sizing Catheter RPN N5
Company / brand
Cook Incorporated
Lot / serial / date codes
UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191
Distribution
US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
Agency product description and boundaries

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).

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Cook Incorporated

Recalls naming this model

FDA Class I · Medical device · May 13, 2026

Aurous Centimeter Sizing Catheter RPN N5 recall — Cook Incorporated

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 fragmentatio…

Company / brand: Cook Incorporated recalls

Affected product: Aurous Centimeter Sizing Catheter RPN N5 recall status

Official ID Z-1935-2026 · Official record ↗

See all Cook Incorporated recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.