Mattress on the Go folding mattresses
Relux Mattress Co. Ltd., of China
🏠 Consumer Products Class I - Dangerous
The mattresses fail to meet the mandatory federal flammability standard for mattresses, posing a fire hazard.
All Recalls
95,025 total recalls in our database
Manhattan Ball
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The toy's plastic tubes can detach from the center ball and release the small silicone teethers that are threaded on the tubes, posing a choking hazard to young children.
Model Year 2015-2020 AXYS Trail Performance and Crossover snowmobiles
Polaris Industries Inc., Medina, Minn.
🏠 Consumer Products Class I - Dangerous
The fuel hose can be improperly secured, posing a fire hazard to consumers.
Rocky Mountain non-electric alloy frame Instinct, Instinct BC and Pipeline bicycles
Rocky Mountain Bicycles, of Canada
🏠 Consumer Products Class II - Moderate
The bicycle's front frame triangle can crack and cause separation of the head tube from the frame, posing fall and injury hazards.
Fresh Express Chopped Kit SOUTHWEST TOTAL NET WT. 11.5 oz (326g) plastic bag. FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30602 5
Fresh Express Incorpated
🍎 Food Class I - Dangerous
The firm learned that, during a single production run, incorrect condiment packets were placed into Southwest Chopped Kit bags and, as a result, the allergens wheat, soy, cashews, and coconut are not properly declared.
A foreign object found by a consumer in dark chocolate bar.
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
SOMERSET THERAPEUTICS
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
💊 Drugs Class I - Dangerous
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
SOMERSET THERAPEUTICS
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
💊 Drugs Class I - Dangerous
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
💊 Drugs Class I - Dangerous
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
SOMERSET THERAPEUTICS
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
💊 Drugs Class I - Dangerous
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations
🏥 Medical Devices Class I - Dangerous
Lack of pouch seal. Product is labelled as sterile.
🏥 Medical Devices Class I - Dangerous
Reports received of the device fracturing during insertion.
🏥 Medical Devices Class I - Dangerous
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Prodimed Plastimed Division
🏥 Medical Devices Class I - Dangerous
Lack of assurance of sterility
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations
🏥 Medical Devices Class I - Dangerous
Lack of pouch seal. Product is labelled as sterile.
🏥 Medical Devices Class I - Dangerous
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.