Medline Convenience Kits Recalled for Potentially Open Breather Pouches
Medline Industries is recalling 706 units of various sterile convenience kits used for gynecological and other procedures due to potential open or weak seals on breather pouches. The packaging defect could affect product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a packaging defect (weak/open seals on breather pouches) that creates a theoretical risk to sterility of medical device kits. No injuries or illnesses are reported in the source text, and the hazard is precautionary rather than confirmed contamination. Per the rubric, a theoretical hazard with no reported adverse events qualifies as Moderate (score 2).
Plain-English summary
Medline Industries, LP is recalling 706 units of Medline Convenience kits used for various procedures, including standard D&C, laparoscopy, gynecological surgery, and robotic-assisted procedures. The recall affects 15 different kit models with specific lot numbers ranging from 24IBE079 to 24LBF830.
The recall is due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile convenience kits. Breather pouches are designed to maintain sterility during storage and transport, and compromised seals could allow contamination.
The affected products were distributed worldwide, including across the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. Healthcare facilities and surgical centers that received these kits should identify products using the provided model numbers and lot numbers and discontinue use.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS.…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 706
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)
- 1) DYNJ69733
- UDI-DI: 10193489974089(each)
- 40193489974080(case)
- Lot Number: 24IBE079
- 2) DYNJ39904A
- UDI-DI: 10888277801905(each)
- 40888277801906(case)
- Lot Number: 24IBF466
- 3) DYNJ64651A
- UDI-DI: 10195327057381(each)
- 40195327057382(case)
- Lot Number: 24IBS312
- 4) DYNJ49250F
- UDI-DI: 10195327680145(each)
- 40195327680146(case)
- Lot Number: 24JBM609
- 5) DYNJ47552C
- UDI-DI: 10193489845594(each)
- 40193489845595(case)
- Lot Number: 24JBN271
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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.
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