Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates
Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.
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: This is a Class II recall involving a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling specific lots of Xcela Power Injectable PICCs with PASV (Cat no. 55-711). The recall is due to incorrect expiration dates on the product labels. The labeled dates extend the shelf life of the product beyond the dates supported by validation testing.
The affected product has not yet reached its validated expiry date. However, the company is removing the product to prevent its use beyond the validated expiry date. The recall involves Lot 5096448, which was distributed to accounts in Florida and to Great Britain.
The recalled product
- Product
- Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1
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)
- Lot 5096448
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Angiodynamics Inc. (Navilyst Medical 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 · Angiodynamics Inc. (Navilyst Medical Inc.)
See all →- ModerateXcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
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