N/A B61029Recalls & reported problems

Black & Black Surgical, Inc. · ASTON SUBMENTAL SS RETRACTOR, 5 1/4''(13.5CM) HANDLE, 6CM X 18MM TAPERED BLADE WITH FIBER-OPTICS · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840329805425), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Overheating of Device1

Patient problems

Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 19, 2025Overheating of Device; Overheating of Device
WE WERE INFORMED THAT DURING A PROCEDURE, A PATIENT WAS BURNED WITH THE FIBEROPTIC RETRACTOR THAT WAS BEING USED.
Patient problems: Burn(s)
MAUDE report 23100260 ↗

Device details

UDI-DI	`00840329805425`
Brand	N/A
Model	B61029
Company	Black & Black Surgical, Inc.
Product code	GAD · RETRACTOR
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 29, 2022

Device type (GMDN): Hand-held surgical retractor, reusable

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

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All RETRACTOR devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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