Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled
Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.
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: This is an FDA Class II medical device recall involving a theoretical risk of patient infection with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported score at most 3.
Plain-English summary
Medline Industries is recalling KIT PEDI CRANI LAMI sterile convenience kits due to a labeling defect affecting 485 units distributed in Texas, Illinois, and California.
A Mastisol component within certain kits is non-sterile but was not labeled as being either sterile or non-sterile. Since users typically assume all components within a sterile convenience kit are sterile, the presence of an undeclared non-sterile component creates an increased risk of patient infection.
Affected units can be identified by the following lot numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, and 22ALA325.
The recalled product
- Product
- KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 485
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)
- UDI/DI Case 40195327060412
- UDI/DI Each 10195327060411
- Lot Numbers: 23ILA372
- 23ILA184
- 23HLB240
- 23HLA567
- 23HLA126
- 23ELA634
- 23DLA974
- 23ALA995
- 22JLA577
- 22HLA985
- 22HLA379
- 22GLB224
- 22GLB099
- 22GLA383
- 22GLA171
- 22DLA615
- 22CLA957
- 22ALA965
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighMedical Laboratory Kit Recalled Due to Non-Sterile Specimen Container
FDA (Devices) · 2024-11-20
- HighUrine kit specimen containers recalled for non-sterile condition
FDA (Devices) · 2024-11-20
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20
- HighSterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
FDA (Devices) · 2023-12-20
- HighNonsterile convenience kit recall due to sterile component mislabeling
FDA (Devices) · 2022-07-27
- HighClean Catch Kit specimen containers recalled for sterility labeling failure
FDA (Devices) · 2024-11-20