HIGHFDA DEVICE

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries, LPHealth & Personal CareMedical DevicesDYNJ54603B UDI-DI 10195327458188 Lot 24ABO124

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 27, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
February 27, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Geographic Scope
1 states

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
Model numbers
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 27, 2026

  2. Reported by FDA DEVICE

    July 1, 2026

  3. RecallRadar source check

    July 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

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

Get instant alerts for Medline Industries, LP recalls

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

No spamUnsubscribe anytime

Full Description

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B. Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.. Classification: Class II. Quantity: 113, 843 kits. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.

Safety Guide

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

Read: How to Get Refunds and Replacements

Want to Know First?

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

Product Classification

Product Details

Model Numbers
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
Affected States
ALL
Report Date
July 1, 2026
Recall Status
ACTIVE

Related Recalls