Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT7600 Integrated System
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 5600 Integrated System (New and Refurbished)
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 3600 Immunodiagnostic System (New and Refurbished)
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- 2024-03-13FDA-DeviceAvanos Medical, Inc.Class IMIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- 2024-03-13FDA-DeviceAvanos Medical, Inc.Class IMIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit wit
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- 2024-03-06FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IILINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
- 2024-03-06FDA-DeviceAcumed LLCClass IIAcu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard,
Distribution without Pre-Market Clearance
- 2024-03-06FDA-DeviceUnited Orthopedic CorporationClass IIUSTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm
Their is a potential that the implant curved stem may be oriented incorrectly.
- 2024-03-06FDA-DeviceUnited Orthopedic CorporationClass IIUSTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm
Their is a potential that the implant curved stem may be oriented incorrectly.
- 2024-03-06FDA-DeviceUnited Orthopedic CorporationClass IIUSTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
Their is a potential that the implant curved stem may be oriented incorrectly.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-HQ190L.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-H190TL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-H190L.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number PCF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number CF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number CF-HQ190L.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number CF-HQ190I.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceOlympus Corporation of the AmericasClass IIColonoscope, Model Number CF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-03-06FDA-DeviceParker Laboratories, Inc.Class IITensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIINS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- 2024-03-06FDA-DeviceIntegra LifeSciences Corp.Class IIRef No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
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