Centimeter Sizing Catheter RPN N5 — Class I medical device recall Z-1934-2026
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-1934-2026 |
|---|---|
| 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 | 11,253 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00827002119161 |
| Lot numbers | 16694273, 16694275, 16694277, 16694279, 16694280, 16696441, 16696442, 16699177, 16699179, 16699182, 16699267, 16700945, 16700946, 16700947, 16700948, 16700948X, 16700949, 16700950, 16700951, 16703557, 16703558, 16707899, 16707901, 16707903, 16711577, 16711578, 16711579, 16711580, 16711581, 16713192, 16713193, 16713194, 16716741, 16716742, 16716743, 16716744, 16716745, 16716746, 16716747, 16716748 and 460 more |
Product
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.
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-1934-2026. 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.