Merit Medical Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0749-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze

Product Classification:

Class II

Date Initiated: November 10, 2020

Date Posted: January 6, 2021

Recall Number: Z-0749-2021

Event ID: 86831

Reason for Recall:

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

Status: Terminated

Product Quantity: 90 kits

Code Information:

(01)00884450255803 Lot # T1883210

Distribution Pattern:

US distribution to: KY, RI, and MD

Voluntary or Mandated:

Voluntary: Firm initiated