Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2017 | AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Cathet... | Arrow International initiated the recall due to reports of safety cover disengagement and needles... | Class II | Arrow International Inc |
| Mar 20, 2017 | Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard ... | Arrow International initiated the recall due to reports of safety cover disengagement and needles... | Class II | Arrow International Inc |
| Mar 20, 2017 | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The A... | Arrow International initiated the recall due to reports of safety cover disengagement and needles... | Class II | Arrow International Inc |
| Mar 20, 2017 | Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectab... | Arrow International initiated the recall due to reports of safety cover disengagement and needles... | Class II | Arrow International Inc |
| Mar 17, 2017 | Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheteri... | Arrow International is recalling due to possible voids in the catheter hub, which could lead to a... | Class II | Arrow International Inc |
| Mar 7, 2017 | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... | Class II | Aesculap Implant Systems LLC |
| Mar 6, 2017 | Syngo.via, Picture archiving and communication system Syngo via is a softwar... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software ... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 3, 2017 | The CG+ Arrow PIC Catheters permit venous access to the central circulation t... | Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithro... | Class II | Arrow International Inc |
| Feb 27, 2017 | Axiom Artis fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2017 | Artis Zee and Zeego fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2017 | Artis Q and Q.Zen fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2017 | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states ... | Class II | Medical Components, Inc dba MedComp |
| Feb 22, 2017 | ARTIS Q, Interventional Fluroscopic x-ray system | In Artis systems with A100G generators, a component can be affected by aging which could result i... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... | Software updates | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ARTISTE" MV System | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Mevatron M2/Primus Mid-Energy PRIMUS HI | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Expression ONCOR" Impression ONCOR" Impression plus | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Avant-garde | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 13, 2017 | Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 | This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modul... | Class II | New Era Orthopaedics, LLc |
| 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 |
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.