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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 3,539
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.
Part of a larger recall action
This product is one of 21 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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