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wilson-cook medical inc.medicalHigh PriorityActive

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.

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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 15, 2026.

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Key facts

Date announced
February 25, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Wilson-cook medical inc.
Category
medical
Source agency
FDA
Announced
February 25, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 / TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
February 25, 2026
Last reviewed by RecallRadar
March 15, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 / TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the wilson-cook medical inc. recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1362-2026&limit=1

Keep browsing with these internal hubs: wilson-cook medical inc. recall hub and Medical recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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