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Showing 6321–6340 of 8389 results

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Starling Monitor (Baxter) – Labeling Compliance (2022)

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

FDASep 2, 2022Nationwide• Baxter Healthcare Corporation

Veritas Advanced Infusion Packs (Johnson & Johnson) – Broken Irrigation Luer (2022)

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

FDASep 1, 2022AL, AZ, AR +22 more• Johnson & Johnson Surgical Vision, Inc.

Surgical Gown (Texas Medical) – Hydrostatic Pressure Failure (2022)

Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.

High

FDASep 1, 2022Nationwide• Texas Medical Technology Inc.

Recreo Hair Growth Laser Comb (Zero Gravity) – Missing Warning Labels (2022)

The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

FDASep 1, 2022Nationwide• OMM Imports, Inc. dba Zero Gravity

Introcan Safety FEP (B Braun Medical) – Catheter Hub Leakage (2022)

Potential for leakage at the catheter hub.

FDASep 1, 2022AZ, CA, FL +12 more• B Braun Medical Inc

Rover Mobile X-Ray System (Micro-X) – DAP Meter Calibration Error (2022)

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

FDAAug 31, 2022Nationwide• Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia

Trackmaster Treadmill TMX428 (Full Vision) – Circuit Latch Condition (2022)

This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.

FDAAug 31, 2022GA, NY, WI• Full Vision Inc

UV Germicidal Wand (PhoneSoap) – Radiation Exposure Risk (2022)

Excessive ultraviolet-C radiation

FDAAug 30, 2022Nationwide• PHONESOAP

Hammertoe Compression Implant Kit (Synthes) – Drill Pin Compatibility (2022)

Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

FDAAug 30, 2022Nationwide• Synthes (USA) Products LLC

BN II System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

BN ProSpec System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

Pinnacle3 Radiation Planning System (Philips) – Dose Export Error (2022)

When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

FDAAug 30, 2022CA, FL, GA +18 more• Philips Medical Systems (Cleveland) Inc

Iso-Gard Filter S Expandi-Flex (Teleflex) – Device Splitting Risk (2022)

Incidents of device splitting or detaching during use

FDAAug 29, 2022Nationwide• TELEFLEX LLC

Power Knee (Ossur) – Battery Dislodge Risk (2022)

Battery may dislodge from the Power Knee

FDAAug 29, 2022Nationwide• Ossur Americas

Catheter Mount (Teleflex) – Device Splitting Risk (2022)

Incidents of device splitting or detaching during use

FDAAug 29, 2022Nationwide• TELEFLEX LLC

Iso-Gard Filter S (Teleflex) – Device Splitting Risk (2022)

Incidents of device splitting or detaching during use

FDAAug 29, 2022Nationwide• TELEFLEX LLC

Iso-Gard Filter S (Teleflex) – Device Splitting Risk (2022)

Incidents of device splitting or detaching during use

FDAAug 29, 2022Nationwide• TELEFLEX LLC

BiPAP V30 Auto (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

OmniLab Advanced+ (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

BiPAP A40 (Philips) – VOC Off-Gassing Risk (2022)

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

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