Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Guardia Access Embryo Transfer Catheter is used for transferring IVF Recalled by Cook Inc. Due to Bent transfer catheter tips may cause difficulty or...
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 Cook Inc. directly.
Affected Products
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Quantity: 400
Why Was This Recalled?
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
Where Was This Sold?
No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report