Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity. |
| Quantity | 400 |
| 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. |
| Initiated | 2019-10-03 |
| Classified | 2019-11-16 |
| Terminated | 2020-05-13 |
| Recall number | Z-0416-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-0416-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84108/
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