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
- Convenience Kits
- Model numbers
- 1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020, 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
- 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 convenience kits are used in healthcare settings for various medical procedures. They typically contain essential sterile components needed for patient care and surgery.
Why This Is Dangerous
Calibration issues with the sterilization equipment may compromise the sterility of the convenience kits. This can lead to an increased risk of infections in patients if the kits are used.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should cease using the affected convenience kits to avoid potential health risks. This recall highlights the importance of effective sterilization practices in medical devices.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or product.
- Look for the lot numbers: 21BBP020 for DYNJ35363A and 24JBB041 for SPTPCD10005.
- Verify the devices against the recall notification.
Where to find product info
Model numbers and lot numbers are typically found on the product label or packaging.
What timeline to expect
Expect a response within 4-6 weeks for refunds or replacements after contacting Medline.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Follow up via email or phone if no response is received within a reasonable timeframe.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Buy medical devices from reputable manufacturers with verified sterilization processes.
- Check for certifications and compliance with safety standards before purchase.
- Stay informed on recalls and safety alerts for medical products.
Documentation advice
Keep records of your purchase, including receipts and any correspondence related to the recall.
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Product Details
The recall involves two models: Drape Pack (Model Number: DYNJ35363A) and Sick Kids-General Custom Split (Model Number: SPTPCD10005). Both models were distributed worldwide, including across the U.S. and are classified as Class II devices.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 240 units
- Affected models: DYNJ35363A, SPTPCD10005
- Hazard classification: Class II
- No reported injuries or incidents
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Safety Guide
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