Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 27, 2019
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the… - a moderate-severity action.
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the… was recalled by Cook Inc. in November 27, 2019. Reason: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the gui…. Check the official notice for the remedy. Verify recall #Z-0415-2020 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the gui….
- Moderate
- severity level
- 202 units
- affected scope
- Class II
- classification
- November 27, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0415-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0415-2020) was formally reported on November 27, 2019, with the manufacturer initiating the action on October 3, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 202.
The documented reason for this recall is: 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 proce… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
202
Related Recalls
6
3 from same agency
Product description
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0415-2020 |
| Date reported | November 27, 2019 |
| Date initiated | October 3, 2019 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 202 |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0415-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.. Recalled by Cook Inc.. Units affected: 202.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0415-2020.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0415-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.