FDA (Device enforcement)

11,102 recalls · page 66 of 112

• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810402023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810452023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810752023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800552023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820502023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820552023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820602023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820652023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820702023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820752023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820802023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820852023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820902023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120820952023-05-25
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 1120821002023-05-25
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800252023-05-25
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800302023-05-25
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800352023-05-25
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800402023-05-25
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 1124800452023-05-25
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 1001810552023-05-25
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 1001810602023-05-25
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 1001810652023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 1003800252023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 1003800352023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 1003800402023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 1003800452023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 1003800502023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 1003820252023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 1003820402023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 1003820452023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 1003820552023-05-25
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 1003820602023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800352023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800402023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800452023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800502023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800552023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800602023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800652023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800702023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117800802023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810352023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810502023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810552023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810602023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810652023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810702023-05-25
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 1117810802023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800502023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800602023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800652023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800702023-05-25
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800802023-05-25
• Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.2023-05-25
• Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use2023-05-25
• Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L84059102023-05-25
• Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L84059602023-05-25
• Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L84059612023-05-25
• Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L84069102023-05-25
• Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L84069112023-05-25
• Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L84069602023-05-25
• Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L84069612023-05-25
• Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 65072023-05-24
• NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 1001002023-05-24
• SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 2023-05-23
• SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x12023-05-23
• SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,2023-05-23
• SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.2023-05-23
• SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.2023-05-23
• SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.2023-05-23
• PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.2023-05-23
• PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).2023-05-23
• PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).2023-05-23
• PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.2023-05-23
• PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.2023-05-23
• PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).2023-05-23
• DiagnosUS Pregnancy Test Midstream REF 100-172023-05-22
• DiagnosUS Ovulation Predictor Midstream REF 200-172023-05-22
• Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;2023-05-22
• Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G213462023-05-22
• BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 12023-05-22
• ARROW Endurance Extended Dwell Peripheral Catheter System2023-05-19
• Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed2023-05-19
• NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed2023-05-19
• DigitalDiagnost C90, Model No. 712034 and 7120352023-05-19
• Contour¿ next GEN Blood Glucose Monitoring System2023-05-19
• QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 6912232023-05-19
• HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 7010678402023-05-18
• BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 7010678592023-05-18
• BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 7010679052023-05-18
• QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 7010678952023-05-18
• QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 7010678232023-05-18
• BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 7010678292023-05-18
• QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 7010704162023-05-18
• QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 7010703882023-05-18
• Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 7010704452023-05-18
• QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-2023-05-18
• QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 7010703882023-05-18
• QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 7010678592023-05-18