Medline Blood Culture Collection Kits Recalled for Expired Internal Components
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a product defect where internal components are expired despite the kit's stated expiration date. This creates a risk of compromised sterility in a critical diagnostic device. No illnesses or injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling 4,850 adult blood culture collection kits (model ADLT BLOOD CULTURE COLLECT KIT, Reference DYNDH1245). The affected kits include lot numbers 23EMI373, 23EMF712, 23DMF155, and 23CMH026.
The recall was issued because components contained within the kit have expired before the overall kit expiration date printed on the insert. This discrepancy means users relying on the insert's expiration date may inadvertently use expired components, potentially compromising the sterility or function of the collection process.
The kits were distributed nationwide with distribution noted in California. Blood culture collection kits are used by healthcare facilities to collect blood samples for diagnostic testing.
The recalled product
- Product
- ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 4,850
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 (5)
- UDI/DI 40889942604723 (case)
- 10889942604722 (unit): Lot Numbers: 23EMI373
- 23EMF712
- 23DMF155
- 23CMH026
Distribution
Part of a larger recall action
This product is one of 5 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 5 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 components
See all →- HighMedline Recalls Central Line Blood Culture Kits Over Expired Components
FDA (Devices) · 2023-11-22
- HighMedline Peripheral Blood Culture Draw Kits Recalled Due to Expired Components
FDA (Devices) · 2023-11-22
- HighScalpel and StatLock in HydroPICC kits expire before label indicates
FDA (Devices) · 2022-11-16
- ModerateSildenafil 80 mg capsules recalled for expired components and labeling errors
FDA (Drugs) · 2020-02-05
- ModerateSquaric Acid Topical Solution Recalled for Incorrect Labeling and Expired Components
FDA (Drugs) · 2020-02-05
Similar recalls
- 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
- HighMedline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
FDA (Devices) · 2024-02-07
- ModerateMedline Blood Culture Collection Kit Recalled for Undocumented Component Expiration
FDA (Devices) · 2024-02-07
- ModerateMedline Blood Culture Kits recalled for inaccurate expiration dating
FDA (Devices) · 2024-02-07
- ModerateBlood Culture Bottle Kit Recalled for Expired Component Documentation Issue
FDA (Devices) · 2024-02-07