The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0658-2025·Announced 2024-12-25

Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which requires a minimum severity score of 4 per the rubric. The hazard involves potential structural failure of a critical component in a surgical instrument used during delicate eye procedures. No reported illnesses or deaths are mentioned in the source text.

Plain-English summary

Kirwan Surgical Products, LLC is recalling the Walcott Bipolar Pencil 25 Gauge Straight (Model RX14-5011), a disposable microsurgical instrument designed for use in eye surgery and other soft tissue procedures, particularly for retinal cauterization during surgical operations.

The outer stainless-steel tube of the pencil may break or detach during use. This defect poses a serious risk during surgical procedures where the instrument is relied upon for precision work.

Approximately 3,010 units have been distributed worldwide, including throughout the United States, Puerto Rico, and 20 other countries. All units with expiration dates from September 1, 2027, onward are included in the recall.

Healthcare facilities and surgeons using these instruments should stop use immediately and contact Kirwan Surgical Products for instructions on returning or replacing affected units.

The recalled product

Product
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the…
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
3,010

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model/Catalog Number: RX14-5011. GTINs: Pouch - 00841019109922
  • Inner Pack - 10841019109929

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Kirwan Surgical Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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