Medline Dental Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling select sterile dental convenience kits due to potential open or weak seals on breather pouches. The compromised seals could allow contamination of sterile products.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves potentially compromised sterile packaging on medical devices, which poses a theoretical risk of product contamination, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling select sterile dental convenience kits (models DYNJ84880, DYNJ56229A, PHS807626F, DYNJ41929D, DYNJ51841C, and DYNJ905551C) due to potential open or weak seals on breather pouches used for packaging these sterile products. The recall affects approximately 573 units distributed worldwide, including the United States, Canada, Mexico, Panama, and the Virgin Islands.
Breather pouches are designed to maintain the sterility of medical devices during storage and transport. If the seals on these pouches are compromised, the sterile environment of the packaged kits may be affected, potentially allowing bacterial contamination and microbial growth.
Healthcare facilities and dental offices that have received these kits should verify the integrity of the breather pouch seals before use. If seals appear open, weak, or damaged, the affected kits should not be used. Customers with questions should contact Medline Industries.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841
- 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) DYNJ84880
- UDI-DI: 10195327432140(each)
- 40195327432141(case)
- Lot Number: 24JBL926
- 2) DYNJ56229A
- UDI-DI: 10198459108105(each)
- 40198459108106(case)
- Lot Number: 24JBV124
- 3) PHS807626F
- UDI-DI: 10198459028045(each)
- 40198459028046(case)
- Lot Number: 24JBV611
- 4) DYNJ41929D
- UDI-DI: 10198459160585(each)
- 40198459160586(case)
- Lot Number: 24JBW877
- 5) DYNJ51841C
- UDI-DI: 10195327522186(each)
- 40195327522187(case)
- Lot Number: 24KBA623
Distribution
Distributed nationwide across the United States.
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