HIGHFDA DEVICE

Medline Surgical Kits Recalled Over Sterility Concerns

Medline Industries recalled 9,051 surgical kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers and poses a high hazard risk. Patients and healthcare providers should stop using these products immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) CDS983069GUDI-DI: 10193489923926(each)40193489923927(case)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 7, 2026
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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 Kits
Model numbers
1) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399, 2) CDS983069G, Lot Number: 21HBO921, 3) CDS983069I, UDI-DI: 10195327071868(each) +6 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 7, 2026

  2. Reported by FDA DEVICE

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. 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's surgical kits are utilized in various medical procedures, providing essential instruments and materials for healthcare professionals. These kits are critical in ensuring the safety and effectiveness of surgical operations.

Why This Is Dangerous

Calibration issues in sterilization equipment can lead to insufficient sterilization of the kits, increasing the risk of infection in patients. This is particularly concerning in surgical settings where sterility is paramount.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers should act quickly to return these products to avoid potential health risks associated with compromised sterility.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers against the recalled list provided by Medline.
  2. Look for lot numbers on the packaging to verify if your kit is affected.
  3. Contact your healthcare provider if you're unsure about your product.

Where to find product info

Model and lot numbers can typically be found on the product packaging or label attached to the kit.

What timeline to expect

Expect processing times for refunds or replacements to take 4-6 weeks after returning the recalled products.

If the manufacturer is unresponsive

  • Document all communications with Medline regarding the recall.
  • Follow up with a call if you do not receive a response within two weeks.
  • Consider filing a complaint with the FDA if the company is unresponsive.

How to prevent similar issues

  • Always check for product recalls before purchasing surgical supplies.
  • Look for certifications indicating successful sterilization processes.
  • Ask healthcare providers about the latest recalls related to surgical kits.

Documentation advice

Keep records of your purchase, return communications, and any correspondence with Medline regarding the recall.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall includes various surgical kits such as CHP Cochlear Supplement CDS (Models CDS983069G, CDS983069I) and ENT Head and Neck Kits (Models DYKMBNDL156, DYNJ41169). These kits were distributed worldwide, including the U.S., from various healthcare facilities.

Key Facts

  • Recall date: January 7, 2026
  • Report date: February 25, 2026
  • Quantity recalled: 9,051 units
  • Risk level: High
  • Affected models: 70 different model numbers

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) CDS983069G
UDI-DI: 10193489923926(each)
40193489923927(case)
Lot Number: 21IBD399
2) CDS983069G
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

Related Recalls