Medline Nurse Training Kits Recalled for Sharp Tracheostomy Brush
Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall with confirmed bristle detachment incidents and potential for user injury from sharp edges, though no actual injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling two educational training kits: the Nurse Kit (SKU EDUC1025) and Nursing Tote Kit (SKU EDUC5056A). The tracheostomy brush component has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, the brush bristles can detach prior to use in packaging and/or during use.
A total of 550 kits have been distributed nationwide throughout the United States, including Puerto Rico. International distribution also occurred to Canada, Panama, and the United Arab Emirates. The affected lot numbers are 22JDB315 and 22HDC340 for SKU EDUC1025, and 22HDC201 and 22HDA420 for SKU EDUC5056A.
The products are labeled as non-sterile devices 'For Training Purposes Only, Not For Human Use' and are intended for educational settings rather than clinical use.
The recalled product
- Product
- (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 550
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 (2)
- (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340
- and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420.
Distribution
Part of a larger recall action
This product is one of 3 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 3 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 · sharp edge
See all →- HighOBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges
FDA (Devices) · 2026-08-19
- HighMRI Machine Coil Seal Adhesive May Create Sharp Edges
FDA (Devices) · 2024-02-07
- SevereMedline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect
FDA (Devices) · 2024-01-03
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03
- HighTarget Recalls Decorative Mailbox Due to Laceration Hazard
CPSC · 2021-12-10
Similar recalls
- SevereMedline Nursing Education Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
- CriticalMedline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions
FDA (Devices) · 2024-03-06
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- HighMedline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
FDA (Devices) · 2018-09-26
- SevereMEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06