Browse Device Recalls
1,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,550 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 1,550 FDA device recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2012 | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator... | Unintended Fluid ingress into the device header has been shown. | Class II | Advanced Neuromodulation Systems Inc. |
| Mar 27, 2012 | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal phot... | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator ma... | Class II | Nidek Inc |
| Mar 27, 2012 | GE Healthcare, Advantage Workstation, READY View Application. Image analys... | GE Healthcare has become aware that when analyzing fMRI images using the READY View application s... | Class II | GE Healthcare, LLC |
| Mar 27, 2012 | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. | When using the "Favorites" function for saved settings, there is potential for a mismatch between... | Class II | Topcon Medical Laser Systems, Inc |
| Mar 27, 2012 | CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to i... | In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly... | Class II | Maquet Cardiovascular, LLC |
| Mar 26, 2012 | TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Ci... | During an FDA inspection, the firm was notified of Quality System deficiencies, which included la... | Class II | Tango3 LLC |
| Mar 23, 2012 | Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. b... | Brush battery cap was forcibly blown off at the end of the brush handle. | Class II | Colgate Palmolive Company |
| Mar 23, 2012 | Infusomat(R) Space Pump (US Version) with software version 686G030103 (common... | Firm became aware of the potential for breakage of the anti free flow clip catch, located on the ... | Class I | B. Braun Medical, Inc. |
| Mar 23, 2012 | Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750... | Brush battery cap was forcibly blown off at the end of the brush handle. | Class II | Colgate Palmolive Company |
| Mar 23, 2012 | Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. ... | Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters,... | Class II | B. Braun Medical, Inc. |
| Mar 23, 2012 | Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 ... | Brush battery cap was forcibly blown off at the end of the brush handle. | Class II | Colgate Palmolive Company |
| Mar 23, 2012 | Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate... | Brush battery cap was forcibly blown off at the end of the brush handle. | Class II | Colgate Palmolive Company |
| Mar 23, 2012 | Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft ... | Brush battery cap was forcibly blown off at the end of the brush handle. | Class II | Colgate Palmolive Company |
| Mar 23, 2012 | ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile ... | Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth o... | Class II | Biomet 3i, LLC |
| Mar 22, 2012 | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. T... | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/... | Class II | Extremity Medical LLC |
| 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 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 | 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 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 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 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 15, 2012 | Sunquest Laboratory Sunquest Laboratory is intended for use by professiona... | Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, ... | Class II | Sunquest Information Systems, Inc. |
| Mar 14, 2012 | Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: Ult... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 14, 2012 | UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: ... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 14, 2012 | UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: U... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 13, 2012 | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two p... | Decrease reactivity of R 1 component. | Class II | Medtest Holdings, Inc. |
| Mar 13, 2012 | STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading... | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can... | Class II | Advanced Sterilization Products |
| Mar 12, 2012 | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpie... | Product may have wrong large product identification label with symbols on the box indicating a S9... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 9, 2012 | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc B... | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Princeton Biomeditech Corp |
| Mar 9, 2012 | Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation ... | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Princeton Biomeditech Corp |
| Mar 9, 2012 | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Roa... | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Princeton Biomeditech Corp |
| 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 7, 2012 | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vit... | Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit inc... | Class II | Abbott Point Of Care Inc. |
| Mar 7, 2012 | S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision... | Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput ... | Class II | Aesculap Implant Systems LLC |
| Mar 7, 2012 | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 ... | DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner be... | Class II | DePuy Orthopaedics, Inc. |
| Mar 6, 2012 | GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Op... | Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomogra... | Class II | GE Healthcare, 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 |
| Mar 1, 2012 | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA... | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. | Class II | Abbott Point Of Care Inc. |
| 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 | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used... | Braemar has recently became aware of a battery related incident that occurred with EWT battery pa... | Class II | BRAEMAR, INC. |
| 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 24, 2012 | Siemens syngo.plaza. Radiological image processing system | Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2012 | Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VI... | Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, ... | Class II | Tosoh Bioscience Inc |
| Feb 22, 2012 | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX,... | Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due t... | Class II | Biomet Spine, LLC |
| Feb 22, 2012 | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is a... | Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading t... | Class II | American Optisurgical Inc |
| Feb 21, 2012 | The brand name of the device is AlgiNot, a dental impression material. Produ... | The firm recalled the product because it may cure harder than expected within the shelf life, wh... | Class II | Kerr Corporation |
| Feb 21, 2012 | Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-... | The firm recalled due to a potentail problem with the position of the hold in the lug teminals on... | Class II | Toshiba American Medical Systems Inc |
| Feb 21, 2012 | Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Pr... | During an internal quality inspection, the tibia plateau was found to be out of specification. T... | Class II | Aesculap Implant Systems |
| Feb 20, 2012 | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW D... | The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 109... | Class II | Vital Signs Devices, a GE Healthcare Company |
| Feb 20, 2012 | FLOW-I Anesthesia System The system is intended for use in administrating ... | A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ... | Class I | Maquet Cardiovascular Us Sales, Llc |
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.