Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2017 | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 m... | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to becom... | Class II | Olympus Corporation of the Americas |
| Feb 3, 2017 | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angi... | Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 31, 2017 | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. ... | These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820... | Class II | Synthes (USA) Products LLC |
| Jan 25, 2017 | MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SI... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of t... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS Medical charged-particle radiation therapy system Product Usage: T... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical Th... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ARTISTE MV System, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Avant-garde, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2017 | Vascular catheter introduction kit The PICC is indicated for short or long t... | There have been complaints for peel away sheaths flaring | Class II | Arrow International Inc |
| Jan 11, 2017 | Syngo.plaza, picture archiving and communications system. | Software update for improvements and to resolve several issues | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2017 | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product... | Software error | Class II | Siemens Medical Solutions USA, Inc |
| Jan 9, 2017 | GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories | Generators may have a faulty component which could impact the proper functioning of the device. | Class II | Aesculap Implant Systems LLC |
| Dec 29, 2016 | Synthes Radial Head Prosthesis System, Surgical instrument motors and accesso... | There is the possibility that the radial stem may loosen post-operatively at the stem bone interf... | Class II | Synthes (USA) Products LLC |
| Dec 22, 2016 | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bo... | The product is being recalled due to incidence and reports of the product breaking during surgery. | Class II | Flower Orthopedics Corporation |
| Dec 12, 2016 | URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope | Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) bu... | Class II | Olympus Corporation of the Americas |
| Dec 12, 2016 | Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The U... | Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending ... | Class II | Olympus Corporation of the Americas |
| Dec 8, 2016 | Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis syst... | Siemens initiated a corrective action to address two possible, mutually independent causes of a s... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 8, 2016 | Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis sys... | Siemens initiated a corrective action to address two possible, mutually independent causes of a s... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 1, 2016 | TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobi... | The interface between the TB3 back and tilt base can separate when tilted beyond the specified an... | Class II | Pride Mobility Products Corp |
| Nov 29, 2016 | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/I... | The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to ... | Class II | Synthes (USA) Products LLC |
| Nov 22, 2016 | SOMATOM Scope, Computed tomography x-ray system | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 22, 2016 | SOMATOM Scope Power, Computed tomography x-ray system | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 22, 2016 | SOMATOM Perspective, Computed tomography x-ray system | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connect... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | SOMATOM Definition Flash System, x-ray, tomography, computed Intended to pro... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produc... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | SOMATOM Definition Edge System, x-ray, tomography, computed Intended to prod... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 10, 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t... | Class III | OraSure Technologies, Inc. |
| Nov 7, 2016 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses ... | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Integ... | Class II | Bayer Healthcare |
| Nov 3, 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Software malfunction that results in incorrect generation or display of error codes. | Class II | Olympus Corporation of the Americas |
| Nov 2, 2016 | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM ... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATO... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMAT... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems ... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis syste... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm ... | Class II | Synthes (USA) Products LLC |
| Oct 31, 2016 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible... | Non-conforming material used. | Class II | Synthes (USA) Products LLC |
| Oct 28, 2016 | Gomco Circumcision Clamps with separate O-Ring Component: The device is packa... | Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. | Class II | Aesculap Implant Systems LLC |
| Oct 28, 2016 | Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 28, 2016 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 20, 2016 | SOMATOM Force, System x-ray, tomography, computed | Siemens is providing software update version VA50A_SP3 to address the software bugs that were i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition Flash system, x-ray, tomography, computed | Hardware issue that may expose the user to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS system, x-ray, tomography, computed | Hardware issue that may expose the User to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM ... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition Flash, Computed tomography system Product Usage: SOMAT... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, 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.