Every US product recall. One feed.

Data refreshed July 27, 2026 · last 180 days

503recalls · last 30 days
40CPSC · last 30 days
394FDA · last 30 days
66NHTSA · last 30 days
3FSIS · last 30 days
3,579in 180-day window

Orthofix U.S. LLC recalls

RecallSweep is tracking 4 recall notices naming Orthofix U.S. LLC in the last 180 days, issued by FDA. The most recent is dated July 22, 2026. They cover Medical Devices.

This page lists what the issuing agencies published. It is not a statement about Orthofix U.S. LLC beyond those notices — open each official notice for the authoritative detail.

Recall notices naming Orthofix U.S. LLC

4 recalls.

FDA Class II Medical Devices

Orthofix U.S. LLC: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Affected quantity: 48 units

Hazard
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Details
Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None. Recall #Z-2729-2026, initiated 20260610. Voluntary: Firm initiated.

Products affected
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Recall status
Ongoing

Look up recall #Z-2729-2026 in the FDA enforcement database ↗
FDA Class II Medical Devices

Orthofix U.S. LLC: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

Affected quantity: 32 units

Hazard
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Details
Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None. Recall #Z-2731-2026, initiated 20260610. Voluntary: Firm initiated.

Products affected
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

Recall status
Ongoing

Look up recall #Z-2731-2026 in the FDA enforcement database ↗
FDA Class II Medical Devices

Orthofix U.S. LLC: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

Affected quantity: 62 units

Hazard
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Details
Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None. Recall #Z-2732-2026, initiated 20260610. Voluntary: Firm initiated.

Products affected
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

Recall status
Ongoing

Look up recall #Z-2732-2026 in the FDA enforcement database ↗
FDA Class II Medical Devices

Orthofix U.S. LLC: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Affected quantity: 19 units

Hazard
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Details
Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None. Recall #Z-2730-2026, initiated 20260610. Voluntary: Firm initiated.

Products affected
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Recall status
Ongoing

Look up recall #Z-2730-2026 in the FDA enforcement database ↗

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