Lower riskMedical device recall · FDA · Published October 3, 2019
Cook Guardia Access Nano Embryo Transfer Catheter Recall: Bent Tips May Cause IVF Transfer
Cook recalls Guardia Access Nano Embryo Transfer Catheters that may bend, causing difficulty inserting during IVF embryo transfers. Affected units may require repeat procedures or additional IV: cycles.
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.
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Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Guardia Access Nano Embryo Transfer Catheter Recall: Bent Tips May Cause IVF Transfer.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66906-cook-guardia-access-nano-embryo-transfer-catheter-recall-bent-tips. Based on FDA recall #Z-0415-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2020%22&limit=1).
The FDA announced on October 3, 2019, that Cook Inc. is recalling Guardia Access Nano Embryo Transfer Catheters due to bent tips that may prevent proper insertion. The agency issued recall number Z-0415-2020 for the Class II device.
How to tell if you have it
Brand: Cook
Product: Guardia Access Nano Embryo Transfer Catheter
Lot Number: 9502915
The hazard
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification (November 12, 2021), Cook Skinny Needle with Chiba Tip Recall (October 13, 2021), and Cook Transseptal Needle with Catheter Recall (October 8, 2021). Additional similar recalls include Cook Centimeter Sizing Catheters Recall (April 2, 2026), Cook Aurous Sizing Catheters Recall (April 2, 2026), and Stryker BARD Dynamic Tip Steerable Catheter Recall (April 10, 2026).
How to tell if you have this one
Check for the lot number 9502915 on the catheter packaging. The product is used for transferring IVF embryos into the uterine cavity.
Brand
Cook
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-0415-2020
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.; Lot Number 9502915
202
Z-0416-2020
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.; Lot Number 8361746
400
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot number 9502915 on the catheter packaging to confirm if it's affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0415-2020 (October 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0415-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.