May 15, 2024Medical DevicesFDA
Philips Ultrasound, Inc. recalls 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr
Hazard: Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
May 15, 2024Medical DevicesFDA
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ
Hazard: Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
May 15, 2024Medical DevicesFDA
Vyaire Medical, Inc. recalls Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used
Hazard: Potential of the nozzle separating during patient use.
May 15, 2024Medical DevicesFDA
Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Hazard: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
May 8, 2024Medical DevicesFDA
Philips North America Llc recalls The Oncology Essentials Package of the Spectral CT imaging system.
Hazard: Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
May 8, 2024Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir
Hazard: Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
May 8, 2024Medical DevicesFDA
SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF
Hazard: Potential interference with the anti-fall system.
May 8, 2024Medical DevicesFDA
Innomed, Inc. recalls INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Hazard: 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
Stryker Neurovascular recalls The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d
Hazard: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
May 8, 2024Medical DevicesFDA
Noah Medical recalls Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended
Hazard: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
May 8, 2024Medical DevicesFDA
Covidien recalls Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Hazard: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
May 8, 2024Medical DevicesFDA
Covidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Hazard: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
May 8, 2024Medical DevicesFDA
Zimmer, Inc. recalls ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stab
Hazard: Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention