Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
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: This is a Class II medical device recall for a risk-of-harm product (sterile surgical kits) where the hazard is loss of sterility assurance if seals are compromised. No illnesses or injuries have been reported, making this a theoretical hazard, which per the rubric qualifies for score 3 (High).
Plain-English summary
Medline Industries is recalling certain medical procedure convenience kits that were packaged in breather pouch lot 323080002. The affected products include multiple kit types for cardiac procedures, vascular access, and other surgical applications. The recall concerns potential compromises to sterility assurance if the vendor seal on the pouch is opened or unsealed.
The recall affects approximately 2,631 units distributed worldwide, including the United States (nationwide), Canada, and Panama. The kits were distributed under multiple product references with specific lot numbers listed in the FDA recall notice.
Healthcare facilities and medical professionals who have received these kits should immediately cease use and contact Medline Industries. The kits should not be used if there is any indication that the pouch seal has been compromised.
The recalled product
- Product
- Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- package-integrity
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 (20)
- a) REF CDS983202I
- UDI/DI 40195327164677 (each)
- 10195327164676 (case)
- Lot Numbers: 23LBI662
- b) REF DYNDC2486A
- UDI/DI 40889942648055 (each). 10889942648054 (case)
- Lot Numbers: 23LBM830
- c) REF DYNJ01201L
- UDI/DI 40888277744807 (each)
- 10888277744806 (case)
- Lot Numbers: 23LBP126
- d) REF DYNJ0537343G
- UDI/DI 40193489517072 (each)
- 10193489517071 (case)
- Lot Numbers: 23LBP442
- e) REF DYNJ32727A
- UDI/DI 40888277036346 (each)
- 10888277036345 (case)
- Lot Numbers: 24ABB296
- f) REF DYNJ32915B
Distribution
Distributed nationwide across the United States.
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