Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability
Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.
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: The recall is classified as FDA Class II, and the hazard involves the potential use of non-sterile medical devices without sterilization, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 80 units of Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG. These kits are intended for use in NAMIC Cath Lab and Interventional Radiology (IR) settings and consist of devices from the NAMIC Fluid Management product families. The recall is classified as Class II by the FDA.
The recall was initiated because non-sterile kits intended to be sterilized prior to use were sold to accounts that did not have the capabilities to perform sterilization. This creates a risk that the devices may be used without proper sterilization.
The affected products were distributed nationwide, including in the states of California, Colorado, Connecticut, Ohio, Texas, and New York. The recall includes Lot 5554524 with an expiration date of 12/31/2022, as well as a second lot with no recorded lot number or expiration date. Users should stop using these kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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)
- Lot 5554524
- Exp 12/31/2022
- second lot with no lot recorded and no exp identified
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medline Industries Inc 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 8 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility
FDA (Devices) · 2024-05-22
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20
- SevereMedline Medical Kits and Trays Recalled for Non-Sterile Solutions
FDA (Devices) · 2024-03-06
- SevereMedline Surgical Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- HighMedline Recalls Bard MYPICC Kits Due to Potential Sterilization Failure
FDA (Devices) · 2018-07-18