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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 301–320 of 786 recalls

Class IIITerminated

AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Applied Medical Technology Inc

Expired expiration dates are listed on the pouches.

January 19, 2017 · DeviceView details →

Class IIITerminated

VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents

Ortho-Clinical Diagnostics

The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.

January 5, 2017 · DeviceView details →

Class IIITerminated

Optilite IgG4 Kit Product Code: LK009.OPT.A

The Binding Site Group, Ltd.

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

December 23, 2016 · DeviceView details →

Class IIITerminated

AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

Beckman Coulter Inc.

Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

December 21, 2016 · DeviceView details →

Class IIITerminated

Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

PerkinElmer Health Sciences, Inc.

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

December 21, 2016 · DeviceView details →

Class IIITerminated

DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

PerkinElmer Health Sciences, Inc.

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

December 21, 2016 · DeviceView details →

Class IIITerminated

AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

PerkinElmer Health Sciences, Inc.

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

December 21, 2016 · DeviceView details →

Class IIITerminated

Roth Net Polyp Retrieval

US Endoscopy Group Inc

The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.

December 13, 2016 · DeviceView details →

Class IIITerminated

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

PerkinElmer Health Sciences, Inc.

Unique Device Identifier (UDI) is missing from outer kit box label.

December 5, 2016 · DeviceView details →

Class IIITerminated

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

Ecolab Inc

The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.

November 30, 2016 · DeviceView details →

Class IIITerminated

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

OrthoPediatrics Corp

Labeled as a 48mm Cortical Screw but measuring at 50mm

November 18, 2016 · DeviceView details →

Class IIITerminated

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

PerkinElmer Health Sciences, Inc.

A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.

November 16, 2016 · DeviceView details →

Class IIITerminated

Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

OraSure Technologies, Inc.

Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.

November 10, 2016 · DeviceView details →

Class IIITerminated

Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

Helena Laboratories, Inc.

Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.

November 7, 2016 · DeviceView details →

Class IIITerminated

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

Smiths Medical ASD, Inc.

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

October 31, 2016 · DeviceView details →

Class IIITerminated

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Diagnostic Hybrids, Inc.

There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

October 26, 2016 · DeviceView details →

Class IIITerminated

VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

Ortho-Clinical Diagnostics

CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.

October 26, 2016 · DeviceView details →

Class IIITerminated

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Euro Diagnostica AB

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

October 21, 2016 · DeviceView details →

Class IIITerminated

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders

Euro Diagnostica AB

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

October 21, 2016 · DeviceView details →

Class IIITerminated

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Euro Diagnostica AB

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

October 21, 2016 · DeviceView details →

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