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 |
|---|---|---|---|---|
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IA... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 8, 2020 | Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Produc... | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. | Class II | Arrow International Inc |
| May 7, 2020 | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be us... | If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum b... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2020 | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within... | Products repaired with the incorrect service manual may be missing an O ring and are subject to r... | Class II | Olympus Corporation of the Americas |
| Apr 30, 2020 | Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-... | Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lea... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 23, 2020 | OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material th... | Class II | Olympus Corporation of the Americas |
| Apr 23, 2020 | ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standal... | Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detectio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 22, 2020 | ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro... | If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Us... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Al... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios A... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 6, 2020 | System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel det... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 6, 2020 | System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2020 | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENG... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Apr 1, 2020 | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LEN... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydroge... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-240 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-160 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 573... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Feb 27, 2020 | Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care ... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, 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.