Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

39226–39250 of 40449

HighFDA (Devices)·Z-0495-2013·2012-12-19
Philips IntelliVue Information Center Recall for Audible Alarm Loss
Philips Healthcare is recalling IntelliVue Information Center software due to a potential loss of audible alarms caused by damaged internal audio cable contacts.
Product
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2013·2012-12-19
Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects
Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.
Product
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0490-2013·2012-12-19
Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue
Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.
Product
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0485-2013·2012-12-19
Roche MagNA Pure LC Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.
Product
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0498-2013·2012-12-19
Voluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure
Covidien is voluntarily recalling specific lots of TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.
Product
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2013·2012-12-19
Roche DataCare POC Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.
Product
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0508-2013·2012-12-19
Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0518-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories
Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.
Product
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0521-2013·2012-12-19
Leica TdT Staining Reagent Recalled for Stability Issues
Leica Microsystems is recalling 322 vials of Novocastra TdT Staining Reagent because the product is not stable up to its expiry date, affecting staining intensity.
Product
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No.…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0484-2013·2012-12-19
Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.
Product
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0483-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect
Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.
Product
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0502-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0512-2013·2012-12-19
Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits
Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test results.
Product
Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0486-2013·2012-12-19
Roche MagNA Pure 96 System Software Recall
Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.
Product
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0492-2013·2012-12-19
Roche DataCara GM Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.
Product
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0511-2013·2012-12-19
Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Folate assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0510-2013·2012-12-19
Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.
Product
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices
Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved by the FDA.
Product
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2013·2012-12-19
Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity
Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.
Product
Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0491-2013·2012-12-19
Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.
Product
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0520-2013·2012-12-19
Advanced Sterilization Products Recalls Sterrad Cyclesure 24 Biological Indicators
Advanced Sterilization Products is recalling Sterrad Cyclesure 24 Biological Indicators because the manufacturer lacks adequate data to support the full labeled shelf-life.
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0507-2013·2012-12-19
Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 because room temperature changes can alter test results.
Product
Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0489-2013·2012-12-19
Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.
Product
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0501-2013·2012-12-19
Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes
Covidien is voluntarily recalling specific lots of Empi STIMC RE Self Adhesive electrodes because manufacturing exposure to an employee with a minor cut may have occurred.
Product
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Category
Medical Device
Distribution
Distributed nationwide

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39226–39250 of 40449