🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Due to the incorrect filter assembly.
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Aomori Olympus Co.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Aomori Olympus Co.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Aomori Olympus Co.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
🏥 Medical Devices Class I - Dangerous
Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)
🏥 Medical Devices Class I - Dangerous
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
10-in-1 Incredible Inventions Science Kits
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Paint on the red and blue magnet contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues. In addition, the product packaging lacks the required warning labels for magnets and balloons.
J Hunt Home and J Hunt and Co. Accent Tables with Charging Receptacles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The convenience charging receptacles and/or USB ports installed in the accent tables can have an electrical issue resulting in reverse polarity, which can pose a shock hazard to the user.
Presto Indoor Electric Smoker
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The heating element/wiring on the smoker is defective, posing an electric shock hazard to consumers.
5-Pack Nose Piercings and Body Bars
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The nose piercings and body bars have elevated levels of nickel, posing a risk of skin irritation.
Toro Power Max Snowthrowers
The Toro Company, of Bloomington, Minn.
🏠 Consumer Products Class II - Moderate
The auger can fail to disengage when the control lever is released, posing an amputation hazard.
NZXT H1 computer cases
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
Metal screws that attach the PCIe riser assembly to the chassis can cause a short in the printed circuit board and overheating, posing a fire hazard due to the circuit board's design.