Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Pneumothorax Tray
- Model numbers
- Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X, Reference Part Number C-UTPTY-1400-WAYNE-112497-IM, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145 +2 more
- Sold at
- Unknown
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
The Wayne Pneumothorax Tray is a medical device component used in thoracic procedures to manage pneumothorax-related steps within a clinical setting.
Why This Is Dangerous
Expiration dates labeled beyond shelf life may compromise sterility or performance, risking patient safety during procedures.
Industry Context
This recall is not part of a broader industry pattern; it relates to mislabeling of expiration dates on specific lots.
Real-World Impact
Healthcare facilities must halt use of affected lots to avoid potential sterility issues and procedural delays.
Practical Guidance
How to identify if yours is affected
- Review Recall Notice Z-1792-2026 and Cook Incorporated communications.
- Match Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH to inventory.
Where to find product info
FDA enforcement page linked in recall notice and Cook Incorporated's recall communications.
What timeline to expect
Refunds or replacements will follow Cook Incorporated procedures; expect weeks to months depending on inventory and provider.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- File a complaint with the FDA if warranted.
How to prevent similar issues
- Verify expiration dates against shelf life during receiving.
- Adopt internal controls for lot-specific expiry labeling.
- Follow standard recalls promptly.
Documentation advice
Keep recall notices, inventory lists, UDI and lot number records, and all communications with Cook or healthcare facilities.
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Product Details
Products from the Wayne Pneumothorax Tray lots were distributed worldwide. Quantity: 318 units. Reference Part Numbers: C-UTPTY-1400-WAYNE-112497-IMH and C-UTPTY-1400-WAYNE-112497-IMH. UDI: 00827002565371(17)261020(10)15719344X; Lot Numbers: 15719344X, 15714808X, 15834145, 15834147. Recall date: 2026-03-05. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Reference Part Numbers: C-UTPTY-1400-WAYNE-112497-IMH
- Recall status: ACTIVE
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Safety Guide
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