Medline sterile medical procedure kits recalled for seal failure risk
Medline is recalling approximately 3,808 sterile medical procedure kits due to potential open or weak seals on breather pouches. Broken seals could expose the devices to contamination.
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: Seal failures on sterile medical device packaging present a risk of contamination and potential patient harm, though no illnesses have been reported. The theoretical hazard of compromised sterility on medical devices used in procedures warrants High severity classification.
Plain-English summary
Medline Industries is recalling 3,808 units of sterile medical procedure convenience kits. The affected kits are packaged with breather pouches that may have open or weak seals, which could be compromised during distribution or storage.
Open or weak seals on sterile medical device packaging could allow contamination of the devices. Patients treated with these kits during medical procedures could be exposed to contaminants if the devices have become contaminated. No injuries or illnesses related to this recall have been reported.
Healthcare facilities that have received these kits should identify affected items by model number and lot number and contact Medline Industries for replacement or return instructions. The kits are distributed in the United States and internationally, including Canada, Mexico, Panama, and the Virgin Islands.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ8243
- 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 (20)
- 1) DYNJ44949C
- UDI-DI: 10193489769227(each)
- 40193489769228(case)
- Lot Number: 24IBS279
- 2) DYNJ41682C
- UDI-DI: 10198459085512(each)
- 40198459085513(case)
- Lot Number: 24JBM452
- 3) DYNJ81267A
- UDI-DI: 10195327352356(each)
- 40195327352357(case)
- Lot Number: 24JBO094
- 4) DYNJ82437A
- UDI-DI: 10198459111006(each)
- 40198459111007(case)
- Lot Number: 24JBT077
- 5) CDS980379J
- UDI-DI: 10195327054908(each)
- 40195327054909(case)
- Lot Number: 24JBT886
Distribution
Distributed nationwide across the United States.
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