Quick Facts at a Glance
- Recall Date
- January 7, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Medline Industries, LP
- Product type
- Drape Pack
- Model numbers
- 1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
The Medline Drape Pack-Choice is a medical device used in healthcare settings for surgical procedures. Consumers purchase this product for its convenience in sterile applications.
Why This Is Dangerous
The calibration issues in sterilization equipment may compromise the sterility of the Drape Pack-Choice, increasing the risk of infection during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using this product may face health risks due to compromised sterility. Immediate action is necessary to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging for DYNJ63118A.
- Verify the lot number: 25ABV005.
- Ensure the product was purchased after January 7, 2026.
Where to find product info
The model number and lot number are typically found on the outer packaging or the product label.
What timeline to expect
Expect 4-6 weeks for refund processing after following recall instructions.
If the manufacturer is unresponsive
- Follow up with Medline Industries via phone or email.
- Document your communications with the company.
- Consider reporting to CPSC if no response is received.
How to prevent similar issues
- Look for FDA-approved medical devices in the future.
- Check for recent recalls before purchase.
- Verify product sterility certifications.
Documentation advice
Keep records of purchase receipts, recall notices, and correspondence with the manufacturer.
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Product Details
The recalled product is Medline's Drape Pack-Choice, Model Number DYNJ63118A. It was distributed worldwide, including the US, but specific retailers are not identified. The recall affects 72 units.
Key Facts
- Recall Date: January 7, 2026
- Quantity Recalled: 72 units
- Hazard Classification: Class II
- Affected Model: DYNJ63118A
- Reported incidents: None reported
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Safety Guide
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