March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System (New and Refurbished)
Hazard: 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.
March 13, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS 3600 Immunodiagnostic System (New and Refurbished)
Hazard: 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.
March 13, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -
Hazard: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
March 13, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec
Hazard: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
March 6, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting
Hazard: Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
March 6, 2024Medical DevicesFDA
Acumed LLC recalls Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef
Hazard: Distribution without Pre-Market Clearance
March 6, 2024Medical DevicesFDA
United Orthopedic Corporation recalls USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 -
Hazard: Their is a potential that the implant curved stem may be oriented incorrectly.
March 6, 2024Medical DevicesFDA
United Orthopedic Corporation recalls USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x1
Hazard: Their is a potential that the implant curved stem may be oriented incorrectly.
March 6, 2024Medical DevicesFDA
United Orthopedic Corporation recalls USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 -
Hazard: Their is a potential that the implant curved stem may be oriented incorrectly.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-Q180AL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-HQ190L.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190TL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190L.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190DL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H180AL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number CF-Q180AL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number CF-HQ190L.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number CF-HQ190I.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Colonoscope, Model Number CF-H180AL.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Parker Laboratories, Inc. recalls Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Hazard: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the b
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid s
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brai
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.