Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates
Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.
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 labeling error involving expiration date mismatch on medical device components. No illnesses or injuries have been reported. The primary risk is confusion over correct component expiration dates, which healthcare facilities can address through visual inspection and inventory verification.
Plain-English summary
Medline Industries is recalling 760 Adult Blood Culture Collection Kits (Reorder #: DYNDH1632, Lot 22FMF305) distributed in California.
The kits contain components with incorrect expiration dates. Specifically, the expiration dates listed on the kit packaging do not match the expiration dates printed on the CHG Solution and Bactec bottle plastic components included in the kit.
This discrepancy creates confusion about the correct expiration date for the product components and could potentially result in the use of expired materials if the actual component date is later than the kit label. Healthcare facilities using these kits should verify the actual expiration dates on the individual components before use.
Consumers and healthcare facilities in possession of affected kits should contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 760
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: (01)40193489916141 (case)
- (01)10193489916140 (kit)
- Lot Number: 22FMF305
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 · expiration date mismatch
See all →- ModerateEXCOR pediatric blood pump valves carry mismatched inner package expiration dates
FDA (Devices) · 2026-06-17
- HighMedline Blood Culture Kits recalled due to mismatched component expiration dates
FDA (Devices) · 2022-11-02
Similar recalls
- 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
- ModerateMedline Blood Culture Collection Kit Recalled for Undocumented Component Expiration
FDA (Devices) · 2024-02-07
- HighMedline Blood Culture Collection Kit Recalled for Expired Bactec Component
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 Kits Recalled: Expired Component Not Disclosed on Insert
FDA (Devices) · 2024-02-07