The Recall Desk
HighFDA (Devices)·Z-2231-2024·Announced 2024-07-10

Medline surgical convenience kits recalled due to weak Pure Pouch seals

Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device recall involving potential sterility compromise in surgical instruments used in open-heart procedures. The hazard is theoretical—weak seals may fail and breach sterility—with no reported illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 7,673 Medline Open Heart CDS non-sterile convenience kits (Pack #CDS981759C) containing Pure Pouch components with weak seals. The affected kits were distributed nationwide to 23 states including Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming.

The Pure Pouch component has weak seals that may fail, potentially resulting in a breach of the sterility of the surgical instruments contained in the kits. A breach in sterility could allow contamination of the instruments before they are used in surgical procedures.

The recall involves lot numbers 24ADA460 (expiration 7/31/2025), 23KDB724 (7/31/2025), 23JDA205 (10/31/2025), 23IDA683 (11/30/2025), and 23EDA124 (5/31/2025). No illnesses or injuries have been reported in connection with this recall. Hospitals and surgical facilities that have received these kits should stop using them and contact Medline Industries for return or replacement instructions.

The recalled product

Product
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical instruments / Convenience kits
Hazard
Affected units
7,673

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Pack #CDS981759C - Lot numbers 24ADA460
  • exp. 7/31/2025
  • 23KDB724
  • 23JDA205
  • exp. 10/31/2025
  • 23IDA683
  • exp. 11/30/2025
  • and 23EDA124
  • exp. 5/31/2025
  • UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 9 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · seal failure

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