Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  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 561–580 of 1,000 recalls

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 · Device
View 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 →
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 anti-cardiolipin IgM 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

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

OMNI LIFE SCIENCE

Incorrect lot number on outer kit

October 14, 2016 · DeviceView details →
Class IIITerminated

Brilliance iCT Computed Tomography X-ray system, Model 728306

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
Class IIITerminated

Ingenuity Core Computed Tomography X-ray system, Model 728321

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
Class IIITerminated

Brilliance ICT SP Computed Tomography X-ray system, Model 728311

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
Class IIITerminated

IQon Spectral CT Computed Tomography X-ray system, Model 728332

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
Class IIITerminated

Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
Class IIITerminated

Ingenuity CT Computed Tomography X-ray system, Model 728326

Philips Medical Systems (Cleveland) Inc

The product label does not include the correct current rating.

October 13, 2016 · DeviceView details →
← PreviousPage 29 of 50Next →