Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect in a medical device used for embryo transfer. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters with Obturator (PPB623). The recall involves 37,620 units distributed worldwide, including the United States and numerous international markets. The specific lot codes affected are listed in the source data.
The recall was initiated because the catheter may be unable to pass through the outer sheath during an embryo transfer procedure. These catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. The defect could interfere with the completion of the medical procedure.
The source text does not report any specific injuries or illnesses associated with this defect. Consumers and healthcare providers should stop using the affected units and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 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 Catheters have the…
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 37,620
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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