Medline Anesthesia Circuit Kits Recalled for Dimensional Variation
Medline is recalling three models of anesthesia circuit kits due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 1920 units distributed worldwide.
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 with no reported illnesses or injuries. The issue is a dimensional assembly quality problem rather than a direct patient safety hazard, qualifying it as a moderate precautionary quality recall.
Plain-English summary
Medline Industries, LP is recalling three models of medical procedure kits used in anesthesia procedures. The affected products are the Anesthesia Circuit Adult (REF DYNJAAF6666B), Anesthesia Circuit Peds-LF (REF DYNJAP9918A), and CV Anesthesia Room Set Up (REF DYNJ905503F) kits. A total of 1920 units have been affected.
The kits contain a slight dimensional variation that has the potential for increased difficulty fitting into the outer canister. This dimensional issue may impact the proper assembly and use of the kits in anesthesia procedures.
The affected kits have been distributed worldwide, including to healthcare facilities in the United States and internationally in Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Healthcare facilities that have received these products can identify affected units using the provided lot numbers and reference numbers.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,920
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 DYNJAAF6666B
- UDI/DI 40195327505838 (case)
- 10195327505837 (unit)
- Lot Numbers: 22EBD700
- 22GBK692
- 22KBE980
- 23DBF522
- 23GBU504
- 23IBJ329
- 23LBD558
- b) REF DYNJAP9918A
- UDI/DI 40195327505883 (case)
- 10195327505882 (unit)
- Lot Numbers: 22EBC460
- 22HBK483
- 22IBT280
- 22JBC030
- 22KBG647
- 23IBM414
- c) REF DYNJ905503F
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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