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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 541–560 of 1,000 recalls

Class IIOngoing

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

Olympus Corporation of the Americas

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

February 12, 2026 · DeviceView details →

Class IIOngoing

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

Olympus Corporation of the Americas

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

February 12, 2026 · DeviceView details →

Class IIOngoing

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

Olympus Corporation of the Americas

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

February 12, 2026 · DeviceView details →

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Erbe USA Inc

Probes may rupture/burst during activation

February 12, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Wrap Aprons.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Leg Wraps.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Half Aprons.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Vest

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Demi Half Aprons.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

CareFusion 303, Inc.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Kilt Blockers.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Protective Sleeves.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Frontal Aprons

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Blockers.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Waldemar Link GmbH & Co. KG (Mfg Site)

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Thyroid Shield.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Caps.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, Kilt

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

Class IIOngoing

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Burlington Medical, LLC

Potential for attenuation degradation over time, decreasing the lifespan.

February 11, 2026 · DeviceView details →

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