Atrium Medical Recalls 28 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 28 Fr Trocar catheters because the packaging label incorrectly depicts more holes than the product actually contains.
What this means for you
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: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect icon) with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Atrium Medical Corporation is recalling 7,043 cases of 28 Fr Trocar catheters, sterile, Model Number 8428. The product is intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
The recall was initiated because the trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. This is a labeling discrepancy regarding the visual representation of the device's features.
The affected units were distributed worldwide, including in the USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela. All lot codes are affected. Consumers and healthcare providers should verify the labeling on their inventory and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Hazard
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 (1)
- All lot codes
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 8 recalled by Atrium Medical Corporation 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 · Atrium Medical Corporation
See all →- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft separation reported in ADVANTA VXT medical devices
FDA (Devices) · 2024-06-12
- HighVascular graft recalled due to slider component separation risk
FDA (Devices) · 2024-06-12
- HighVascular graft devices recalled due to slider component separation
FDA (Devices) · 2024-06-12
- HighVascular graft component separation reported in ADVANTA VXT devices
FDA (Devices) · 2024-06-12
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02