Ciaglia Blue Rhino recallZ-1781-2026 · Cook Incorporated · initiated Mar 5, 2026

Why it was recalled

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

FDA root cause category: Incorrect or no expiration date

What the company is doing

Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Recall details

Recall number

Z-1781-2026

Status

Open, Classified

Initiated by the company

Mar 5, 2026

Posted by the FDA

Apr 6, 2026

Recalling firm

Cook Incorporated

Quantity

484 units

Product code

JOH

FDA submissions

K133597

Distribution

Worldwide distribution.

Product description

COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Ciaglia Blue Rhino G12115

  Cook Incorporated · Tube tracheostomy and tube cuff
  1 recall2 reports
• Ciaglia Blue Rhino G32092

  Cook Incorporated · Tube tracheostomy and tube cuff
  1 recall0 reports

Product lines

• Ciaglia Blue RhinoCook Incorporated · 7 models · 10 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 98495).

• Z-1775-2026 · Open, Classified
  COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
• Z-1776-2026 · Open, Classified
  COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
• Z-1777-2026 · Open, Classified
  COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
• Z-1778-2026 · Open, Classified
  COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
• Z-1779-2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA…
• Z-1780-2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-…
• Z-1783-2026 · Open, Classified
  COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-…
• Z-1784-2026 · Open, Classified
  COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
• Z-1785-2026 · Open, Classified
  Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number …
• Z-1786-2026 · Open, Classified
  COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
• Z-1787-2026 · Open, Classified
  COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
• Z-1788-2026 · Open, Classified
  COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24…
• Z-1789-2026 · Open, Classified
  COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-R…
• Z-1790-2026 · Open, Classified
  COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
• Z-1791-2026 · Open, Classified
  COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
• Z-1792-2026 · Open, Classified
  COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number …