Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 1, 2013 | DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear ... | It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems | Class II | Elekta, Inc. |
| May 1, 2013 | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. ... | There has been an increase in complaints regarding the needle/safety mechanism disengaging from t... | Class II | Becton Dickinson & Company |
| May 1, 2013 | Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers... | Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct ... | Class II | Applied Medical Resources Corp |
| Apr 30, 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 T... | American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable han... | Class II | American Optisurgical Inc |
| Apr 30, 2013 | SlingBar Wide 670. Designed to meet the needs for lifting humans. | Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... | Class II | Hill-Rom, Inc. |
| Apr 30, 2013 | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | SlingBar 360. Designed to meet the needs for lifting humans. | Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... | Class II | Hill-Rom, Inc. |
| Apr 30, 2013 | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ ... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medication... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries... | Product fails to meet the accuracy at the low end of the measuring range. | Class II | Wako Life Sciences, Inc. |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... | Class II | American Optisurgical Inc |
| Apr 30, 2013 | Integrity 3.0 Product Usage: The Agility multileaf collimator is indicate... | Unexpected movement during beam delivery may not be detected if there are incorrect static tolera... | Class II | Elekta, Inc. |
| Apr 30, 2013 | SlingBar Standard. Designed to meet the needs for lifting humans. | Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... | Class II | Hill-Rom, Inc. |
| Apr 30, 2013 | SlingBar 350. Designed to meet the needs for lifting humans. | Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... | Class II | Hill-Rom, Inc. |
| Apr 30, 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes... | TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible trans... | Class II | TZ Medical Inc. |
| Apr 30, 2013 | EZ Breathe Medication Cup. For the delivery of liquid medications for resp... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 29, 2013 | Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Syst... | Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which invo... | Class II | Biomet, Inc. |
| Apr 26, 2013 | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasi... | On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... | Class II | Heart Sync, Inc |
| Apr 26, 2013 | Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic s... | The firm became aware of a potential issue with Axiom Artis systems installed by a third party in... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 26, 2013 | Active Articulation E1. Intended for use with either primary or revision h... | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this actio... | Class II | Biomet, Inc. |
| Apr 26, 2013 | MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The... | MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Apr 26, 2013 | AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Per... | Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it ... | Class II | Beckman Coulter Inc. |
| Apr 26, 2013 | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic ... | On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... | Class II | Heart Sync, Inc |
| Apr 26, 2013 | Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biph... | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire wh... | Class II | Cardio Medical Products |
| Apr 25, 2013 | ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Ef... | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... | Class II | The Anspach Effort, Inc. |
| Apr 25, 2013 | B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoass... | Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interferen... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 25, 2013 | Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Comp... | A complaint was received in which a hospital physicist indicated the dosage was too high on the H... | Class II | Leibel-Flarsheim Company LLC |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are... | Malfunction of slap hammer. | Class II | SpineFrontier, Inc. |
| Apr 25, 2013 | Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 ... | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. | Class II | Instratek, Incorporated |
| Apr 25, 2013 | ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effor... | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... | Class II | The Anspach Effort, Inc. |
| Apr 25, 2013 | BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medic... | Philips has received one report from the field that there was an unexpected motion of the detecto... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2013 | ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, In... | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... | Class II | The Anspach Effort, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Man... | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... | Class II | The Anspach Effort, Inc. |
| Apr 25, 2013 | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an ... | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may r... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 24, 2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilato... | Calibration error for Embla Embletta Gold units calibrated through service center between June 15... | Class II | Embla System Llc |
| Apr 23, 2013 | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... | Class II | Cordis Corporation |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... | Class II | Cordis Corporation |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... | Class II | Cordis Corporation |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... | Class II | Cordis Corporation |
| Apr 23, 2013 | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... | Class II | Cordis Corporation |
| Apr 22, 2013 | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for... | Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 22, 2013 | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan ... | Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were... | Class II | SpineFrontier, Inc. |
| Apr 22, 2013 | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ... | CareFusion has received four (4) customer reports of a component (oxygen connector) within the re... | Class II | Carefusion 2200 Inc |
| Apr 22, 2013 | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Bi... | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indi... | Class II | Advanced Sterilization Products |
| Apr 22, 2013 | HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) fo... | Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
| Apr 22, 2013 | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). ... | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power ... | Class II | Fisher & Paykel Healthcare, Ltd. |
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.