Medline Medical Procedure Kits Recalled for Dimensional Variation
Medline Industries recalled 3,539 medical procedure kits due to a dimensional variation that may prevent proper fitting into their outer storage canister. The FDA classified this as a Class II recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a dimensional variation affecting product fit and function. No illnesses, injuries, or hospitalizations have been reported. The hazard is operational in nature and the recall appears precautionary.
Plain-English summary
Medline Industries, LP is recalling 3,539 units of medical procedure kits across three variants: Major Breast (REF DYNJ905004C), Minor Breast (REF DYNJ905002B), and Suction Medi Vac (REF DYKM2033).
A dimensional variation in the kits may cause increased difficulty when fitting them into their outer storage canister. The FDA has classified this as a Class II recall.
The affected kits were distributed worldwide, including in the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Specific affected lot numbers are identified in the FDA recall notice for each product variant.
Healthcare facilities and organizations with affected lots should verify their inventory against the identified lot numbers and contact Medline Industries for guidance on the recall.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- dimensional-variation
- packaging-fit
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)
- a) REF DYNJ905004C
- UDI/DI 40195327316939 (case)
- 10195327316938 (unit)
- Lot Numbers: 23CBG213
- 23EBI690
- 23FBT057
- 23GBB635
- 23IBA478
- 23JBB064
- b) REF DYNJ905002B
- UDI/DI 40195327316861 (case)
- 10195327316860 (unit)
- Lot Numbers: 23ABK521
- 23BBG561
- 23CBU161
- 23EBE334
- c) REF DYKM2033
- UDI/DI 40193489849241 (case)
- 10193489849240 (unit)
- Lot Numbers: 22FMF595
Distribution
Distributed nationwide across the United States.
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