PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Polymer Technology Systems
🏥 Medical Devices Class I - Dangerous
Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
All Recalls
95,075 total recalls in our database
6376 M-1 Cot Fastener, catalog no. 6376000000
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
Non-sterile product was packaged inside a case that was labeled as sterile.
SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
🏥 Medical Devices Class I - Dangerous
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
BD MAX DNA MMK Lab Use, catalog no. 442828
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
🏥 Medical Devices Class I - Dangerous
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Beijing Syntech Laser Trixel C02 Laser surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Specialized bicycles with Stout cranks
Specialized Bicycle Components, Inc., of Morgan Hill, Calif.
🏠 Consumer Products Class II - Moderate
The driveside crankarm can disengage and cause the rider to lose control, posing fall and injury hazards.
Women's scarves
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The women's scarves fail to meet the federal flammability standard for clothing textiles, posing a risk of burn injuries to consumers.
Hauck Nerf® Battle Racer go-karts
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The steering wheel on the go-kart can detach, break or crack while in use, posing a laceration and/or collision hazard to young children.
ITALIAN ROSE GARLIC SPREAD, Gluten Free, NET WT. 35 LB (16 kg), www.italian-rose.com, Riviera Beach, FL 33404
Italian Rose Garlic Products
🍎 Food Class I - Dangerous
During a FDA inspection, it was disclosed that the firm is not documenting the mixing time of the product nor is pH monitoring for each kettle/batch mixed being conducted. The product is a shelf stable garlic spread.
Shell Eggs packaged in quantities and styles of pack (plastic and pulp cartons, flats, and boxes)
ROSE ACRE FARM
🍎 Food Class I - Dangerous
Shell eggs have the potential to be contaminated with Salmonella Braenderup.
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
AdvoCare International
🍎 Food Class I - Dangerous
Undeclared milk in a dietary supplement
Some decorated (iced) Easter cookies in the shapes of eggs, bunnies and chicks sold in bulk bins in 9 northern CA Whole Foods locations do not properly declare egg as an ingredient or allergen.
Bloody Hell Mary, HOT, Kitchen By The Sea, From the Beach House, Net Wt. 32 oz. (.9L), Low Sodium
Kitchen By The Sea
🍎 Food Class I - Dangerous
allergen warning not listed on labels , egg, soy and wheat including sulfites
Parotta Family Pack, UPC: 8 70400 00084 5, Frozen; and Small Parotta, UPC: 870400000012, Frozen
Maharaja Food Importers
🍎 Food Class I - Dangerous
Label states ghee, but does not declare milk.
WHOLE WHEAT PAROTTA, UPC: 8 70400 00092 0
Maharaja Food Importers
🍎 Food Class I - Dangerous
Label states ghee, but does not declare milk.