SPS Sterilization Recalls Edwards Lifesciences Aortic Cannula Due to Labeling Error
SPS Sterilization is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas because the expiration date on the label exceeds the validated shelf life.
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 and involves a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SPS Sterilization, Inc. is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas, 24F x 37.6CM, that were resterilized. The recall was initiated because the expiration date printed on the device labeling exceeds the actual validated shelf life of the product. This occurred because the sterilization process used did not have adequate support for the extended shelf life indicated on the label.
The affected devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The specific Code Number is EZC24A-R, and the Lot Number is 59634962. The recall includes 37 specific serial numbers ranging from 16401032017-01 to 16401032017-37.
Healthcare facilities and consumers should stop using these specific devices and contact SPS Sterilization, Inc. for further instructions or a return. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Manufacturer
- SPS Sterilization, Inc
- Hazard
- Affected units
- 6
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 (20)
- Code Number EZC24A-R
- Lot Number 59634962
- Serial Numbers 16401032017-01
- 16401032017-02
- 16401032017-03
- 16401032017-04
- 16401032017-05
- 16401032017-06
- 16401032017-07
- 16401032017-08
- 16401032017-09
- 16401032017-10
- 16401032017-11
- 16401032017-12
- 16401032017-13
- 16401032017-14
- 16401032017-15
- 16401032017-16
- 16401032017-17
- 16401032017-18
Distribution
Part of a larger recall action
This product is one of 15 recalled by SPS Sterilization, 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 15 products in this recall →Related recalls
Same manufacturer · SPS Sterilization, Inc
See all →- ModerateSPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Resterilized Aortic Perfusion Cannulas Due to Shelf Life Labeling
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis
FDA (Devices) · 2018-09-19
- ModerateSPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error
FDA (Devices) · 2018-09-19
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