Chromophare Surgical Light System , REF CH00000001
Stryker Communications
🏥 Medical Devices Class I - Dangerous
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
All Recalls
95,083 total recalls in our database
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Human Care Hc Sweden Ab
🏥 Medical Devices Class I - Dangerous
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
🏥 Medical Devices Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
🏥 Medical Devices Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Microbiologics
🏥 Medical Devices Class I - Dangerous
The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
🏥 Medical Devices Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
🏥 Medical Devices Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
🏥 Medical Devices Class I - Dangerous
Medical device components were marketed without FDA clearance and without FDA approval
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
🏥 Medical Devices Class I - Dangerous
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
Synovo Production
🏥 Medical Devices Class I - Dangerous
Medical device components were marketed without FDA clearance
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Hemostasis Probe, Model: CD-B622LA
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
BRS Liquid Fuel Bottles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The portable fuel bottles do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child-resistant, posing a risk of burn and poisoning to children.
Delta Cycle and Dimension Stem Raisers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The Stem Raiser can shift during use, causing the bicycle's handlebar to shift unexpectantly, posing a fall hazard.