FDAClass I · Medical device · Recall Z-1935-2026 · Recalled May 13, 2026
Aurous Centimeter Sizing Catheter RPN N5 recall — Cook Incorporated
Agency report date: May 13, 2026.
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.
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.
2. Agency hazard and consumer action
FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class I: most serious — reasonable probability of serious health consequences or death.
Affected product: Aurous Centimeter Sizing Catheter RPN N5 recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More Cook Incorporated recalls
- Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5 recall — Cook IncorporatedFDA · May 13, 2026
- Centimeter Sizing Catheter RPN N5 recall — Cook IncorporatedFDA · May 13, 2026
Other medical device recalls from around the same time
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- Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adap recall — American Contract Systems IncFDA · May 13, 2026
- Halyard VA DETROIT CATH LAB PACK kit recall — AVID Medical, Inc.FDA · May 13, 2026
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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 11, 2026 at 6:00 PM UTC.