Smiths Medical Recalls Embryo Replacement Catheters Due to Functional Defect
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro and Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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. The hazard is a functional defect preventing the procedure from being completed, with no reported injuries or illnesses in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro and Sure-Pro Ultra Embryo Replacement Catheters (Product Code PE623). These medical devices are used to introduce embryos into the uterine cavity following in vitro fertilization. The Sure-Pro Ultra variant is specifically designed to be visible under ultrasound.
The recall was initiated because the inner catheter is unable to pass through the outer sheath during the embryo transfer procedure. This functional defect prevents the clinician from completing the transfer as intended. The recall covers 22,380 units distributed worldwide, including the United States and numerous international markets.
Healthcare providers and patients who have used or possess these specific catheters should contact Smiths Medical ASD, Inc. for further instructions. The affected lot codes are listed in the official recall documentation.
The recalled product
- Product
- Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement…
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 22,380
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, 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.
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