Thousands of heart surgery kits recalled due to FDA quality concerns

Michael Walter | June 25, 2026 | Cardiovascular Business | Cardiac Surgery

FDA recall medical device recall product recall

Medline, the Illinois-based medical supplier, is recalling thousands of procedure kits used by cardiac surgeons due to quality issues identified during a U.S. Food and Drug Administration (FDA) inspection. The recall includes more than 6,500 cardiovascular procedure kits primarily used during open-heart surgeries, and more than 500 general surgery trays.

All convenience kits contain Lidocaine Hydrochloride Injection, USP and/or Bupivacaine Hydrochloride in Dextrose Injection, USP. Quality issues with these anesthetics are what prompted the recall.

Medline kits included in this recall include certain lots of:

OPEN HEART CDS, Model Number: CDS840144Q
OPEN HEART, Model Number: CDS840150W
OPEN HEART ADULT, Model Number: CDS840396AA
CABG A CDS, Model Number: CDS982269N
OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G
OPEN HEART ACCESSORY CDS, Model Number: CDS984289L
OPEN HEART A, Model Number: CDS985105Q
OPEN HEART PART 2, Model Number: DYNJ901075R
VPH OPEN HEART, Model Number: DYNJ902664L
HEART A, Model Number: DYNJ903465I
HEART, Model Number: DYNJ903822F
OPEN HEART BASIC B, Model Number: DYNJ904311F
SM OPEN HEART PACK A&B, Model Number: DYNJ904749J
OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B
SILVER CROSS OPEN HEART, Model Number: DYNJ906102K
ANESTHESIA OPEN HEART, Model Number: DYNJ906225I
OPEN HEART COMBO, Model Number: DYNJ907400F
CARDIAC CABG B, Model Number: DYNJ908121C
FS OPEN HEART, Model Number: DYNJ908308A
OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D
MEM CARDIAC, Model Number: DYNJ9622573AP
OPEN HEART A & B PACK, Model Number: DYNJ9718008AT

The FDA categorized this as a Class I recall, which means using these devices may cause “serious adverse health consequences or death.”

What customers should do

The affected kits should be quarantined. Medline will send labels to be placed on the kits alerting users to “remove and discard the affected component prior to using the kit.”

“If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication,” the advisory warns.

Click here for more information from the FDA.

Another major recall for Medline

This represents the second major recall in the month of June for Medline. The company previously recalled nearly 50,000 procedure kits used in the cardiac cath lab and other parts of the hospital due to safety concerns about liquid adhesive.