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 |
|---|---|---|---|---|
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument softw... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 15, 2012 | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 15, 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... | Class II | Ossur Americas, Inc. |
| Oct 15, 2012 | MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Produ... | It was found that there is a problem with the LCD monitor used in the console. The LCD monitor ma... | Class II | Toshiba American Medical Systems Inc |
| Oct 15, 2012 | Invivo Corporation Expression MRI Patient Monitoring System. The Expressio... | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi... | Class II | Invivo Corporation |
| Oct 15, 2012 | Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitat... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 12, 2012 | Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 ... | A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch i... | Class II | Synthes USA HQ, Inc. |
| Oct 12, 2012 | Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. ... | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 12, 2012 | Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum... | The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feedin... | Class II | MOOG Medical Devices Group |
| Oct 12, 2012 | GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical too... | GE Healthcare has recently become aware of a potential safety issue associated with the table pa... | Class II | GE Healthcare, LLC |
| Oct 12, 2012 | Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Num... | It was discovered internally that there was a discrepancy between the insert provided with the Tu... | Class II | Synthes USA HQ, Inc. |
| Oct 11, 2012 | The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system de... | Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have be... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 11, 2012 | COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... | Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection... | Class II | Roche Molecular Systems, Inc. |
| Oct 11, 2012 | Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Desig... | Firm has received reports from customers that the small pins at the bottom of the center door pan... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 10, 2012 | PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully aut... | Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Oct 10, 2012 | ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent i... | Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Oct 10, 2012 | MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ce... | A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 ... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 10, 2012 | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Dia... | Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibratio... | Class II | Alfa Wassermann, Inc. |
| Oct 10, 2012 | The product is a lyophilized growth supplement for use with dehydrated cultur... | The product may contain low level microbial contamination which could result in incorrect results. | Class II | Remel 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 10, 2012 | Siemens Mobilette Mira, intended use as Mobile x-ray system. | There is a risk of lost images during examination. | Class II | Siemens Medical Solutions USA, Inc |
| Oct 9, 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assa... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | Digital RID Plate Reader and Software Product Code: AD400 | If a control ring is marked after reading, the software will not flag results that are out of the... | Class II | The Binding Site Group, Ltd. |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 8, 2012 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intend... | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The en... | Class II | Radiometer America Inc |
| Oct 8, 2012 | Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method ... | Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 5, 2012 | Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), ... | Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection softwa... | Class II | Philips Medical Systems (Cleveland), Inc. |
| Oct 5, 2012 | Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP... | Under certain conditions, when using the Search functionality, the potential exists for the wrong... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 5, 2012 | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B T... | Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold th... | Class II | SpineFrontier, Inc. |
| Oct 5, 2012 | The touchscreen display (model 94267) designed for use with the XPREZZON beds... | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights... | Class II | Spacelabs Healthcare, Llc |
| Oct 4, 2012 | BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gaug... | A report of an event was received indicating that upon opening a box containing 10 sterile cannul... | Class II | Baylis Medical Company Inc. |
| Oct 4, 2012 | Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a met... | The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) | Class II | Biomet, Inc. |
| Oct 4, 2012 | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... | Damage to the packaging may have compromised the sterility of the device. | Class II | Ethicon Endo-Surgery Inc |
| Oct 3, 2012 | Repeater Pump, Class II device used for facilitating repeatable drug dosage d... | The firm is issuing a field correction to the operators manual included with the 099 Repeater Pum... | Class II | Baxa Corporation |
| 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 |
| Oct 3, 2012 | STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validat... | Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological In... | Class II | Advanced Sterilization Products |
| Oct 2, 2012 | Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Fran... | BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the... | Class II | Becton Dickinson & Company |
| Oct 2, 2012 | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... | Class II | GE Healthcare It |
| Sep 29, 2012 | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 | Broken screw insertor hardness was measured and found to be below the acceptable limits. | Class II | Ebi, Llc |
| Sep 28, 2012 | 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac... | A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea... | Class II | Encore Medical, Lp |
| Sep 28, 2012 | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pr... | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothro... | Class II | International Technidyne Corp. |
| Sep 28, 2012 | Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, a... | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... | Class II | Biomet 3i, LLC |
| Sep 28, 2012 | Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. ... | The insert provided with the product for the specific lot number indicates that this product is M... | Class II | Synthes USA HQ, 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.