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
- Hazard
- seal-failure
- contamination-risk
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.
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