The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0192-2027·Announced 2026-10-28

Think Surgical Square Driver Recalled for Design Specification Failures

Think Surgical is recalling 15 Square Driver units because they failed to meet design specifications, potentially causing pins to stick or wobble during drilling.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as Class II because the square driver failed to meet design specifications, potentially causing the pin to stick or wobble during drilling. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Think Surgical, Inc. is recalling 15 units of the Think Surgical Square Driver (REF: 109126). The recall was initiated because the robotic system square drive failed to meet design specifications.

The defect may result in the pin becoming stuck in the square driver or the pin wobbling during drilling. The affected units were distributed nationwide in the United States, specifically in the states of New York and Delaware. The lot number is 25356 and the primary DI is M9461091260.

Consumers who possess this product should stop using it and contact Think Surgical, Inc. for further instructions on the recall.

The recalled product

Product
Think Surgical Square Driver REF: 109126
Manufacturer
Think Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
15

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 (1)

  • Lot: 25356/Primary DI: M9461091260

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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