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
- Surgical Gown
- Model numbers
- 1) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525050165, 2) DYNJP2001, Lot Number: 30525070175, 3) DYNJP2001, Lot Number: 30525070223 +4 more
- 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
Medline surgical gowns are used in medical settings to provide protective barriers for healthcare providers and patients during procedures. These gowns are essential for maintaining a sterile environment in operating rooms and other clinical settings.
Why This Is Dangerous
Calibration issues in the sterilization equipment may lead to gowns that are not properly sterile. This lack of sterility can pose serious risks during surgeries and other medical procedures where infection control is critical.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant number of surgical gowns, which may lead to shortages in medical facilities. Healthcare providers must seek alternatives to maintain safety during procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or gown.
- Compare your gown's model number with those listed in the recall.
- Look for any purchase documentation to assist in the return process.
Where to find product info
Model numbers are typically printed on the packaging or labels inside the gowns.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or replacements after submission of the return request.
If the manufacturer is unresponsive
- Document your attempts to contact Medline.
- Consider reaching out via multiple communication channels (phone, email).
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Purchase gowns from reputable medical supply companies that provide clear information about sterilization processes.
- Look for gowns with clear, valid certifications for sterility and quality control.
- Avoid purchasing non-sterile gowns for surgical use.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with Medline regarding the recall.
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Product Details
The recall includes 70,376,042 surgical gowns, with model numbers such as DYNJP2001, DYNJP2001S, and DYNJP2101. These gowns were distributed worldwide and sold in cases containing various quantities. The gowns have been manufactured and distributed since 2026.
Key Facts
- Medline recalled over 70 million surgical gowns
- Calibration issues may compromise sterility
- Stop using gowns immediately
- Contact Medline for further instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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