Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2012 | Analyzing system consists of a small and portable analyzer and plastic microc... | Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... | Class III | HemoCue AB |
| Nov 1, 2012 | VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... | Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... | Class III | Ortho-Clinical Diagnostics |
| Oct 25, 2012 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... | Class III | Volk Optical Inc |
| Oct 22, 2012 | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 22, 2012 | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 10, 2012 | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... | Correlation slope bias and accuracy shift | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 3, 2012 | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 12215... | The firm recalled due to higher reactivity with some samples in the effected lots, which may refl... | Class III | Focus Diagnostics Inc |
| Sep 14, 2012 | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve... | HORIBA Medical Irvine Technical Support received reports from some customers that have experience... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Sep 14, 2012 | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... | This recall was initiated because some customers were experiencing an alarm during Creatinine cal... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Sep 6, 2012 | Sterile, single-use, disposable electrosurgical electrode holder. It connect... | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. ... | Class III | Gynex Corporation |
| Aug 28, 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... | Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... | Class III | Philips Medical Systems (Cleveland) Inc |
| Aug 22, 2012 | Dual Tip Marker, Sterile Product Usage: A writing instrument intended... | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. | Class III | Viscot Medical LLC |
| Aug 20, 2012 | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO... | Class III | Microgenics Corporation |
| Aug 15, 2012 | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m... | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... | Class III | Amsino Medical USA |
| Aug 15, 2012 | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL... | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... | Class III | Amsino Medical USA |
| Aug 7, 2012 | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters be... | Class III | Bard Access Systems |
| Aug 7, 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 7, 2012 | ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ... | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Aug 2, 2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ... | Customers were not following the labeled assay procedure. This was due to a letter issued to them... | Class III | Phadia US Inc |
| Aug 2, 2012 | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... | On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... | Class III | Steris Corporation |
| Jul 31, 2012 | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula... | It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packag... | Class III | Roche Molecular Systems, Inc. |
| Jul 23, 2012 | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys... | Review of instrument software databases and investigation of two customer reports determined that... | Class III | Trek Diagnostic Systems |
| Jul 20, 2012 | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... | Product is missing the label on the internal packaging. | Class III | Teleflex Medical |
| Jul 19, 2012 | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06... | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control ... | Class III | Abbott Point Of Care Inc. |
| Jul 17, 2012 | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408... | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2012 | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual... | Defective camera: There is a possibility that the connection of the wires to the connector may be... | Class III | Berchtold Corp. |
| Jul 9, 2012 | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics pa... | The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control,... | Class III | Iris Diagnostics |
| Jun 20, 2012 | System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ... | During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa... | Class III | Terumo Cardiovascular Systems Corporation |
| Jun 19, 2012 | STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX steri... | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... | Class III | Advanced Sterilization Products |
| Jun 19, 2012 | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX ste... | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... | Class III | Advanced Sterilization Products |
| Jun 7, 2012 | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve... | Class III | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Jun 7, 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 29, 2012 | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code... | The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as run... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Apr 24, 2012 | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... | The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus... | Class III | Ormco/Sybronendo |
| Apr 23, 2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P... | Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG... | Class III | Sigma |
| Mar 30, 2012 | Model 324JL On-Board Suction System Intended use: On-board suction system f... | A shipment mix-up took place. | Class III | Impact Instrumentation, Inc. |
| Mar 28, 2012 | Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... | St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... | Class III | St Jude Medical Inc |
| Mar 22, 2012 | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain Syringing Pipettes 240 (Catalog #490517) | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 19, 2012 | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, Wes... | Ten units of Model EMV+ Devices were shipped out in error before the verification and validation ... | Class III | Impact Instrumentation, Inc. |
| Mar 8, 2012 | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Ind... | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expirati... | Class III | Helix Medical LLC |
| Mar 5, 2012 | BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collecti... | BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Ligh... | Class III | Becton Dickinson & Company |
| Feb 28, 2012 | Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diag... | The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain... | Class III | Critical Diagnostics |
| Feb 24, 2012 | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage... | During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6... | Class III | Roche Molecular Systems, Inc. |
| Feb 15, 2012 | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ... | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates li... | Class III | Medtest Holdings, Inc. |
| Dec 15, 2011 | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ... | The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron... | Class III | Beckman Coulter Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.