HIGHFDA DEVICE

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Medline Industries, LPHealth & Personal CareMedical DevicesMedline Kit SKU DYNJ910103BUDI/DI 10198459346873 (each) 40198459346874 (case)Lot Number 25FBR237

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 11, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 11, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Geographic Scope
9 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
Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237, Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761, Lot Number 25BBD107, Lot Number 25FBD534 +1 more
Where affected
CT, FL, KS, OH, NY, MD, MT, VA +1 more

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 11, 2026

  2. Reported by FDA DEVICE

    July 29, 2026

  3. RecallRadar source check

    August 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.. Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.. Classification: Class II. Quantity: 155 kits. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

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

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Product Classification

Product Details

Model Numbers
Medline Kit SKU DYNJ910103B
UDI/DI 10198459346873 (each) 40198459346874 (case)
Lot Number 25FBR237
Medline Kit SKU DYNJ910961A
UDI/DI 10198459213342 (each) 40198459213343 (case)
+4 more
Affected States
CT, FL, KS, OH, NY, MD, MT, VA, MA
Report Date
July 29, 2026
Recall Status
ACTIVE

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