Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cook
- Product type
- Percutaneous Tracheostomy Introducer Tray
- Model numbers
- Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X, UDI (01)00827002577039(17)260201(10)15476984X +8 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
This is a medical device used in percutaneous tracheostomy procedures to introduce tracheostomy access.
Why This Is Dangerous
Expired shelf life labeling could compromise sterility or device integrity, posing potential patient risk during procedures.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Immediate cessation of use is required; no injuries reported in the notice but potential safety risk during procedures.
Practical Guidance
How to identify if yours is affected
- Check Reference Part Numbers: C-PTISY-100-HC-G-NA, C-PTISY-100-UNL-HC-G-NA, C-PTISY-100-UNS-HC-G-NA.
- Review UDI codes listed.
Where to find product info
Review manufacturer recall notice and FDA enforcement page. Check device packaging for lot number and UDI.
What timeline to expect
Replacement or refund timelines will be provided by Cook Incorporated.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a consumer complaint with the FDA if needed
How to prevent similar issues
- Verify shelf life and expiration labeling for all devices before use in procedures
- Adhere to supplier recalls and hospital procurement protocols
- Maintain up-to-date device inventories and recalls records
Documentation advice
Keep recall notices, lot numbers, UDI codes, purchase records, and all correspondence with Cook.
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Product Details
Brand: Cook. Product: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray. Reference Part Numbers: C-PTISY-100-HC-G-NA (Order G57703); C-PTISY-100-UNL-HC-G-NA (Order G57706); C-PTISY-100-UNS-HC-G-NA (Order G57704). Distribution: Worldwide. Recall Date: 2026-03-05. Report Date: 2026-04-15. Quantity: 441 units. Classification: Class II.
Reported Incidents
No injury or adverse-event data is provided in the recall notice.
Key Facts
- Expiration dates exceed shelf life
- Reference Part Numbers: C-PTISY-100-HC-G-NA, C-PTISY-100-UNL-HC-G-NA, C-PTISY-100-UNS-HC-G-NA
- UDI codes present in records
- Class II recall
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Safety Guide
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