Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-02-01FDA-DeviceGetinge Usa Sales IncClass IGetinge Flow-c Anesthesia System, Part No. 6887700
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
- 2023-02-01FDA-DeviceGetinge Usa Sales IncClass IGetinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
- 2023-01-25FDA-DeviceSiemens Medical Solutions USA, IncClass IILuminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
- 2023-01-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Luminos Agile
There is potential for the footrest to detach from the patient table during use.
- 2023-01-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
There is potential for the footrest to detach from the patient table during use.
- 2023-01-25FDA-DeviceR & D Systems, Inc.Class IIIR&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, contai
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
- 2023-01-25FDA-DeviceBolton Medical Inc.Class IIRELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
The product may be shorter than packaging indicates
- 2023-01-25FDA-DeviceBolton Medical Inc.Class IIRELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
The product may be shorter than packaging indicates
- 2023-01-25FDA-DeviceMaquet Cardiovascular, LLCClass IIVasoshield Syringe Packs, Model VH-5001
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
- 2023-01-25FDA-DeviceMaquet Cardiovascular, LLCClass IIHemopro 2 with Vasoshield, Model VH-4001
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- 2023-01-25FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
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