FDA Device recall Z-1526-2024
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular app…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular app… by Cook, citing packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1526-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-01 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
Product
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377
Reason
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Identifiers
| code_info | UDI: (01)00827002013773(17) Lot Number: 15786588 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-21 · Cook - 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 go…
FDA Device · Class I · 2026-05-13 · Cook - 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 vari…
FDA Device · Class I · 2026-05-13 · Cook - 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-C…
FDA Device · Class I · 2026-05-13 · Cook - COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092
FDA Device · Class II · 2026-04-15 · Cook
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1526-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.