Medline Surgical Convenience Kits Recalled for Weak Breather Pouch Seals
Medline is recalling 9,216 surgical convenience kits due to weak or open seals on breather pouches that could compromise sterility. Affected kits include ENT, T&A, and other procedure packs distributed nationwide and internationally.
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 an FDA Class II recall of sterile medical devices with no reported illnesses or injuries. The weak or open packaging seals pose a potential contamination risk to surgical kits used in procedures, meeting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 9,216 units of various sterile surgical convenience kits due to potential weak or open seals on the breather pouches used for packaging. The affected products include T&A packs, ENT packs, nasal packs, and other procedure-specific kits used in hospitals and surgical facilities.
The weak or open seals could compromise the sterility of the packaged medical devices, potentially allowing contamination before use in surgical and procedural settings. This is a Class II recall by the FDA.
These kits were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands.
Healthcare facilities that have received these products should stop using them. For details on specific model numbers and lot numbers, consult the FDA's official recall notice. Contact Medline Industries or the FDA with any questions about this recall.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-IC
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- weak-seals
- contamination
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) DYNJ67791A
- UDI-DI: 10193489941715(each)
- 40193489941716(case)
- Lot Number: 24IBE758
- 2) DYNJ66514
- UDI-DI: 10193489359282(each)
- 40193489359283(case)
- Lot Number: 24IBE817
- 3) DYNJ67775A
- UDI-DI: 10193489996258(each)
- 40193489996259(case)
- Lot Number: 24IBG346
- 4) DYNJ83158
- UDI-DI: 10195327236885(each)
- 40195327236886(case)
- Lot Number: 24IBG449
- 5) DYNJ0634878I
- UDI-DI: 10195327694500(each)
- 40195327694501(case)
- Lot Number: 24IBG548
Distribution
Distributed nationwide across the United States.
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