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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 141–160 of 230 recalls

Class IIIOngoing

Achieva 1.5T, Model No. 781178, 781196, 781296

Philips North America

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

December 29, 2023 · DeviceView details →
Class IIIOngoing

Achieva 1.5T Conversion, Model No. 781283

Philips North America

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

December 29, 2023 · Device
View details →
Class IIIOngoing

Ingenia Ambition X, Model No. 782109

Philips North America

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

December 29, 2023 · DeviceView details →
Class IIIOngoing

CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

Maquet Medical Systems USA

CARDIOHELP-i System was not properly tested to measure leakage current

November 14, 2023 · DeviceView details →
Class IIIOngoing

Navik 3D v2, REF NAVIK3D, 3D Mapping System

APN Health LLC

IFU update

November 7, 2023 · DeviceView details →
Class IIIOngoing

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

Randox Laboratories Ltd.

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

November 6, 2023 · DeviceView details →
Class IIIOngoing

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Fresenius Medical Care Holdings, Inc.

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

October 24, 2023 · DeviceView details →
Class IIIOngoing

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Aizu Olympus Co., Ltd.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

September 25, 2023 · DeviceView details →
Class IIIOngoing

KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

Microbiologics Inc

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

August 14, 2023 · DeviceView details →
Class IIIOngoing

ZVU Functional GI Software, REF: ZVU-3

Diversatek Healthcare

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

July 25, 2023 · DeviceView details →
Class IIIOngoing

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

Ortho-Clinical Diagnostics, Inc.

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

May 18, 2023 · DeviceView details →
Class IIIOngoing

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

NeuMoDx Molecular Inc

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

May 15, 2023 · DeviceView details →
Class IIIOngoing

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

Randox Laboratories Ltd.

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

May 4, 2023 · DeviceView details →
Class IIIOngoing

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633

Randox Laboratories Ltd.

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

May 4, 2023 · DeviceView details →
Class IIIOngoing

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Datascope Corp.

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

May 4, 2023 · DeviceView details →
Class IIIOngoing

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Abbott Ireland Limited

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

April 24, 2023 · DeviceView details →
Class IIIOngoing

Total Knee Pack, REF CETJ130, medical convenience kits

American Contract Systems, Inc.

Incorrect expiration date on product.

April 17, 2023 · DeviceView details →
Class IIIOngoing

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577

Mechatronics USA

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

April 14, 2023 · DeviceView details →
Class IIIOngoing

RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

Mechatronics USA

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

April 14, 2023 · DeviceView details →
Class IIIOngoing

ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

Olympus Corporation of the Americas

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

March 31, 2023 · DeviceView details →
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