Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—users may use expired components only if they fail to verify the expiration date on the component itself. This is fundamentally a labeling documentation issue without evidence of actual harm.
Plain-English summary
Medline Industries is recalling specific lots of blood culture bottle kits (Reorder Number DYNDH1738A, Lot 23JBM366) distributed nationwide in the United States. The kits contain a Bactec component whose expiration date is not reflected on the kit insert.
There is a risk that users may unknowingly use an expired component if they do not check the expiration date on the Bactec inside the kit.
The recall affects healthcare facilities and laboratories using these specific kit lots.
The recalled product
- Product
- MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 775
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 (3)
- UDI/DI 40195327239849 (case)
- 10195327239848 (unit)
- Lot Numbers: 23JBM366
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · expired component
See all →- ModerateSperm separation media kits recalled for incorrect component lot
FDA (Devices) · 2024-02-14
- ModerateMedline Blood Culture Collection Kit Recalled for Undocumented Component Expiration
FDA (Devices) · 2024-02-07
- HighMedline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
FDA (Devices) · 2024-02-07
- HighMedline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
FDA (Devices) · 2024-02-07
- HighMedline Blood Culture Collection Kit Recalled for Expired Bactec Component
FDA (Devices) · 2024-02-07
Similar recalls
- HighMedline Blood Culture Kits recalled due to mismatched component expiration dates
FDA (Devices) · 2022-11-02
- ModerateBlood Culture Collection Kit Distributed with Mismatched Component Expiration Dates
FDA (Devices) · 2022-11-02
- HighBlood culture kit recalled due to expired internal components
FDA (Devices) · 2023-11-22
- HighBlood Culture Kits Recalled Due to Expired Internal Components
FDA (Devices) · 2023-11-22
- ModerateMedline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-11-02
- HighMedline Recalls Central Line Blood Culture Kits Over Expired Components
FDA (Devices) · 2023-11-22