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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 121–140 of 615 recalls

Class IICompleted

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

Spectrum Medical Ltd.

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

March 13, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

Medacta Usa Inc

There is a potential for breakage of the small screw used to affix the anti-backout plate.

March 8, 2023 · DeviceView details →

Class IICompleted

RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

Appliedvr

There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

February 27, 2023 · DeviceView details →

Class IICompleted

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

Abbott Diabetes Care, Inc.

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

February 9, 2023 · DeviceView details →

Class IICompleted

Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001

Align Technology Inc

3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.

December 5, 2022 · DeviceView details →

Class IICompleted

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

Hologic, Inc

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

October 10, 2022 · DeviceView details →

Class IICompleted

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Fresenius Kabi USA, LLC

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

September 16, 2022 · DeviceView details →

Class IIICompleted

PTS Panels CHOL+GLU Test Strips (REF 1765)

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Incorrect instructions for use were packaged into the final product.

August 16, 2022 · DeviceView details →

Class IICompleted

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

GELITA MEDICAL GMBH

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

July 27, 2022 · DeviceView details →

Class IICompleted

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Abbott Molecular, Inc.

Incorrect optical calibration

July 19, 2022 · DeviceView details →

Class IICompleted

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

Philips Ultrasound, LLC

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

July 14, 2022 · DeviceView details →

Class IICompleted

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Materialise USA LLC

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

July 13, 2022 · DeviceView details →

Class IICompleted

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

SAFE ORTHOPAEDICS LLC

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

June 3, 2022 · DeviceView details →

Class IICompleted

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

Surgical Innovations Ltd

There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

June 2, 2022 · DeviceView details →

Class IICompleted

Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.

Ultradent Products, Inc.

SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.

June 1, 2022 · DeviceView details →

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