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
- Lithotomy Pack
- Model numbers
- 1) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392, 2) DYNJ83185, Lot Number: 23CDB552, 3) DYNJ83185, Lot Number: 23CDA474 +6 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
Lithotomy packs are used in medical procedures to support patient positioning and access. They are essential for gynecological surgeries and related healthcare settings.
Why This Is Dangerous
The calibration issues in sterilization equipment raise the risk that these packs may not be sterile, potentially leading to infections during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using these lithotomy packs, which may cause disruptions in scheduled procedures and potential health risks.
Practical Guidance
How to identify if yours is affected
- Check your lithotomy pack model number against DYNJ83185 and DYNJ83185A.
- Verify the lot numbers against the recalled list: 23FDC392, 23CDB552, 23CDA474, 22LDA486, 24KDB955.
- If your pack matches, cease use immediately.
Where to find product info
Model numbers and lot numbers are typically found on the packaging of the lithotomy packs or in accompanying documentation.
What timeline to expect
Expect a refund processing timeline of 4-6 weeks after submission of your request.
If the manufacturer is unresponsive
- Document all communications with Medline.
- Re-contact Medline if no response is received within a reasonable period.
- Consider filing a complaint with consumer safety authorities if issues persist.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Verify sterilization information and certifications when purchasing medical supplies.
- Consult with healthcare providers about the safety of devices used in procedures.
Documentation advice
Keep copies of any receipts, correspondence related to the recall, and documentation of your request for a refund.
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Product Details
The recall includes two models of lithotomy packs: Model Number DYNJ83185 and DYNJ83185A. The affected products were distributed worldwide, including in the U.S. The kits were sold at an approximate price of $100.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 808 units
- Risk of infection due to calibration issues
- No incidents reported
- Contact Medline for instructions
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Safety Guide
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