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
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 Set
- Model numbers
- Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145, UDI (01)00827002565371(17)260115(10)15834147 +1 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 Set is a specialized medical device used by clinicians to manage pneumothorax during procedures. It is distributed globally to healthcare facilities.
Why This Is Dangerous
Expiration dates printed on labels exceed the true shelf life, potentially affecting device performance or sterility.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Healthcare providers must verify lot numbers and expiration labeling to ensure patient safety. The recall could disrupt device availability and require stock checks.
Practical Guidance
How to identify if yours is affected
- Review the reference part numbers: C-UTPT-1020-WAYNE-IMH
- Review the reference part number: C-UTPT-1400-WAYNE-112497-IMH
- Cross-check associated order numbers G56532 and G56535
- Confirm expiration labeling vs true shelf life
Where to find product info
Recall notices and device identifiers are typically in the FDA enforcement report and Cook Incorporated recall communications.
What timeline to expect
Refunds or replacements will be issued per Cook's recall instructions; timeline not specified in provided data.
If the manufacturer is unresponsive
- Escalate to medical facility compliance officer
- Document all outreach attempts and dates
- Contact FDA adverse event reporting if needed
How to prevent similar issues
- Verify expiration labeling against shelf life before clinical use
- Implement inventory controls to segregate older stock
- Maintain a batch-level traceability system
Documentation advice
Keep device lot numbers, expiration labels, purchase records, and all recall communications.
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Product Details
Recall date: 2026-03-05. Report date: 2026-04-15. Classification: Class II. Quantity: 104 units. Distribution: Worldwide. Reference Part Numbers: C-UTPT-1020-WAYNE-IMH (Order G56532); C-UTPT-1400-WAYNE-112497-IMH (Order G56535).
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Class II recall
- Reference Part Numbers: C-UTPT-1020-WAYNE-IMH; C-UTPT-1400-WAYNE-112497-IMH
- Order numbers: G56532; G56535
- Hazard: expiration dates exceed true shelf life
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Safety Guide
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