FDA Medical devices recall · December 25, 2024

Accutome/Microsurgical Disposable Bipolar Pencil 5 in recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

Product

Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 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 retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Why was it recalled?

Potential for the outer stainless-steel tube to break or detach.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model/Catalog Number: AB-7004. GTINs: Pouch - 00841019113875, Inner Pack - 10841019113872, Case - 20841019113879. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

Distribution

Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.

States: Puerto Rico

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-0656-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.