Medline medical procedure kits recalled due to dimensional variation
Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.
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 with no reported injuries or adverse events. The dimensional variation creates difficulty with product assembly rather than a direct patient safety hazard. The hazard is functional and precautionary rather than a confirmed risk of harm.
Plain-English summary
Medline Industries, LP is recalling approximately 1,700 medical procedure kits (model REF DYKM2169, suction canister kits) due to a dimensional defect detected in the recalled units.
The kits contain a slight dimensional variation that creates the potential for increased difficulty when fitting them into the outer canister. This defect may complicate proper assembly when using the kits in medical procedures.
The affected kits were distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. The affected lot numbers are: 22IBJ207, 22LBP008, 23ABT182, 23BBK494, 23EBN628, 23GBF762, 23IBF429, 23JBH402, and 23LBB872, identifiable by UDI/DI 40195327199969 (case level) and 10195327199968 (unit level).
Healthcare facilities and medical professionals should verify the lot numbers on their supplies against the recall list to identify any affected units.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- Affected units
- 1,700
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 (12)
- a) REF DYKM2169
- UDI/DI 40195327199969 (case)
- 10195327199968 (unit)
- Lot Numbers: 22IBJ207
- 22LBP008
- 23ABT182
- 23BBK494
- 23EBN628
- 23GBF762
- 23IBF429
- 23JBH402
- 23LBB872
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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