Medline Convenience Kits Recalled for Potentially Weak Sterile Seals
Medline Industries is recalling 1126 Convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. Compromised seals may allow contaminants to reach sterile contents, though no illnesses or injuries have been reported.
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: Sterile medical device kits with identified potential for compromised packaging seals present a risk of serious harm through possible contamination. No illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries is recalling Convenience kits used for various medical procedures, including biopsy packs, sperm extraction kits, and drainage/ablation packs. The recalled products consist of 1126 units distributed worldwide across the United States, Canada, Mexico, Panama, and the Virgin Islands.
The recalled kits have been identified as having potential open or weak seals on breather pouches used for packaging. Breather pouches are critical for maintaining the sterility of medical device kits. Compromised seals could potentially allow contaminants to reach the sterile contents of the kits.
No illnesses or injuries have been reported to date. Patients and healthcare providers who have these kits in their possession should stop using them and contact Medline Industries or their healthcare provider for information about replacements.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- compromised-seal
- 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) DYNJ68393A
- UDI-DI: 10193489939996(each)
- 40193489939997(case)
- Lot Number: 24IBP745
- 2) DYNJ81441B
- UDI-DI: 10198459111105(each)
- 40198459111106(case)
- Lot Number: 24JBB770
- 3) DYNJ68303
- UDI-DI: 10193489821529(each)
- 40193489821520(case)
- Lot Number: 24JBU406
- 4) DYNJ41678B
- UDI-DI: 10198459124129(each)
- 40198459124120(case)
- Lot Number: 24JBW438
- 5) DYNJ41678B
- Lot Number: 24JBW452
- 6) DYNJ55215G
- UDI-DI: 10193489925555(each)
Distribution
Distributed nationwide across the United States.
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