Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5 — Class I medical device recall Z-1936-2026
Ongoing recall by Cook Incorporated, reported 2026-05-13, distributed nationwide. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result includ
| Recall number | Z-1936-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CN, CO, CR, HK, IL, IN, JP, KR, NZ, SG, SV, TW, UY |
| Quantity | 4,245 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00827002312135, 00827002312142, 00827002312166, 00827002312203, 00827002312210 |
| Lot numbers | 16661312, 16673569, 16674400, 16680240, 16690050, 16690051, 16693653, 16695772, 16700199, 16704378, 16711110, 16717839, 16720153, 16730325, 16730326, 16734169, 16736740, 16739291, 16739292, 16763024, 16764526, 16766437, 16779437, 16779438, 16782945, 16782946, 16795733, 16795734, 16796300, 16796665, 16800424, 16800730, 16800731, 16802096, 16802097, 16802132, 16802133, 16802282, 16802632, 16802633 and 59 more |
Product
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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1936-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.