Medline Surgical Convenience Kits Recalled Due to Open or Weak Breather Pouch Seals
Medline Industries is recalling 4,094 surgical convenience kits due to potential open or weak seals on breather pouches that could compromise sterility.
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 recall concerns sterile surgical kits where compromise of packaging integrity could lead to contamination. The source text does not report any injuries, hospitalizations, or illnesses, placing this in the High category per the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries, LP is recalling select sterile surgical convenience kits used for various surgical procedures. The recall affects 4,094 units across 33 different kit models designed for plastic surgery, breast procedures, facial/eye procedures, and other applications.
Breather pouches are used to package these sterile kits for storage and transport while maintaining sterility. Some of the breather pouches may have open or weak seals, which could allow the sterile contents to become contaminated before the kits are used.
The affected kits have been distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the Virgin Islands. Healthcare providers and facilities who have received Medline convenience kits should verify whether they have any of the affected models and lot numbers listed in the recall.
Healthcare providers who have received these kits should contact Medline Industries for instructions regarding the affected units.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Mo
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- seal-failure
- 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) DYNJ43914B
- UDI-DI: 10889942437078(each)
- 40889942437079(case)
- Lot Number: 24IBH633
- 2) DYNJ65109
- UDI-DI: 10193489243826(each)
- 40193489243827(case)
- Lot Number: 24IBH739
- 3) DYNJ34160D
- UDI-DI: 10889942213542(each)
- 40889942213543(case)
- Lot Number: 24IBH802
- 4) DYNJ84991
- UDI-DI: 10195327444075(each)
- 40195327444076(case)
- Lot Number: 24IBL195
- 5) DYNJ66056
- UDI-DI: 10193489318128(each)
- 40193489318129(case)
- Lot Number: 24IBR304
Distribution
Distributed nationwide across the United States.
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