Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 27, 2020
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect…
Baylis Medical Company Inc. recalled TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63… - a moderate-severity action.
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63… was recalled by Baylis Medical Company Inc. in May 27, 2020. Reason: There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be comprom…. Check the official notice for the remedy. Verify recall #Z-2069-2020 with the FDA Devices before acting.
The recall
Baylis Medical Company Inc. issued this moderate-severity FDA Devices recall-There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be comprom….
- Moderate
- severity level
- Class II
- classification
- May 27, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2069-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2069-2020) was formally reported on May 27, 2020, with the manufacturer initiating the action on October 7, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Baylis Medical Company Inc. is listed as the recalling firm, operating out of Mississauga, N/A. Federal records list the affected scope as Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits)..
The documented reason for this recall is: There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is us… Distribution data in the federal record shows the product reached: Product distributed throughout the 50 states and in Washington D.C.. 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
Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
Related Recalls
6
3 from same agency
Product description
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
Reason for recall
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2069-2020 |
| Date reported | May 27, 2020 |
| Date initiated | October 7, 2019 |
| Recalling firm | Baylis Medical Company Inc. |
| Firm location | Mississauga, N/A |
| Affected scope | Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits). |
| Distribution | Product distributed throughout the 50 states and in Washington D.C. |
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-2069-2020) 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? ▼
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.. Recalled by Baylis Medical Company Inc.. Units affected: Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits)..
Why was this product recalled? ▼
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2069-2020.
Where was the recalled product distributed? ▼
Distribution: Product distributed throughout the 50 states and in Washington D.C..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2069-2020) 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 May 27, 2020. 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.