🏥 Medical Devices Class I - Dangerous
Medical device components were marketed without FDA clearance and without FDA approval
All Recalls
95,114 total recalls in our database
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.
Fischer RC4 Junior Ski Boots
Fischer Sports US, of Auburn, New Hampshire
🏠 Consumer Products Class II - Moderate
The ski boot cuff can rotate, causing the lock mechanism to malfunction, posing a fall hazard and risk of injury to the consumer.
GhostBed-branded Natural Mattresses
Innovative Bedding Solutions, of Buena Park, California
🏠 Consumer Products Class I - Dangerous
The mattresses violate the smoldering ignition requirements of the federal mattress flammability regulation, posing a fire hazard.
Intimidator and Mahindra branded utility vehicles (UTVs)
Intimidator, of Batesville, Ark.
🏠 Consumer Products Class II - Moderate
The universal joint can fail and pierce and sever the brake line, posing a crash hazard.
Matrix T1 and T3 Series Commercial Treadmills
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The power cord can become loose from the treadmill's power socket, posing a fire hazard.
Red Land Cotton "Quilts" and "Quilted Shams"
Red Land Cotton, Moulton, Alabama
🏠 Consumer Products Class III - Low Risk
Pieces of broken needles were found inside some quilts and quilted shams, posing a laceration hazard.
Touchat Large Fuzzy Area Rugs
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The recalled area rugs violate the mandatory federal flammability regulations for carpets and rugs, posing a fire hazard.
Yoto Mini speakers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The speaker's lithium-ion battery can overheat and catch fire, posing burn and fire hazards to consumers.
Zipline Kits
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The zipline's stainless-steel cable can break, posing a fall hazard.
Powerade Mountain Berry Blast - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
THE COCA-COLA COMPANY
🍎 Food Class I - Dangerous
The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.