Smith & Nephew Recalls Renasys EZ PLUS Canisters for Labeling Changes
Smith & Nephew is recalling Renasys EZ PLUS canisters to modify the bacterial overflow guard and update product labeling.
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 source text explicitly states the reason is labeling changes and filter modification without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew Inc. is recalling 6,871,375 units of the Renasys EZ PLUS canister, a component of the Renasys EZ Negative Pressure Wound Therapy System. The recall involves specific product codes and lot codes ranging from M201498 to M400299.
The recall is being conducted to modify the bacterial overflow guard (filter) and to make related changes to product labeling. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers and healthcare providers should refer to the manufacturer for specific instructions regarding the modification and labeling updates.
The recalled product
- Product
- Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
- Manufacturer
- Smith & Nephew Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 6,871,375
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew 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 2 products in this recall →Related recalls
Same manufacturer · Smith & Nephew Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
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