Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 25, 2026
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Wilson-Cook Medical Inc. recalled Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI cod… - a moderate-severity action.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI cod… was recalled by Wilson-Cook Medical Inc. in February 25, 2026. Reason: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens,…. Check the official notice for the remedy. Verify recall #Z-1362-2026 with the FDA Devices before acting.
The recall
Wilson-Cook Medical Inc. issued this moderate-severity FDA Devices recall-Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens,….
- Moderate
- severity level
- 153 units
- affected scope
- Class II
- classification
- February 25, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1362-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1362-2026) was formally reported on February 25, 2026, with the manufacturer initiating the action on December 18, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wilson-Cook Medical Inc. is listed as the recalling firm, operating out of Winston Salem, NC. Federal records list the affected scope as 153.
The documented reason for this recall is: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. Distribution data in the federal record shows the product reached: U.S. Distribution to states of: CA, CO, IN, and NC.. 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
153
Related Recalls
6
3 from same agency
Product description
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Reason for recall
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1362-2026 |
| Date reported | February 25, 2026 |
| Date initiated | December 18, 2025 |
| Recalling firm | Wilson-Cook Medical Inc. |
| Firm location | Winston Salem, NC |
| Affected scope | 153 |
| Distribution | U.S. Distribution to states of: CA, CO, IN, and NC. |
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-1362-2026) 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? ▼
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.. Recalled by Wilson-Cook Medical Inc.. Units affected: 153.
Why was this product recalled? ▼
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 25, 2026. Severity: Moderate. Recall number: Z-1362-2026.
Where was the recalled product distributed? ▼
Distribution: U.S. Distribution to states of: CA, CO, IN, and NC..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1362-2026) 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 February 25, 2026. 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.