Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Recalled by Smiths Medical ASD, Inc. Due to Unable to pass catheter through outer sheath during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.
Affected Products
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 added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Quantity: 37620 units
Why Was This Recalled?
Unable to pass catheter through outer sheath during embryo transfer
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smiths Medical ASD, Inc.
Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report