Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Subpotent Drug
Missing from associated official evidence: action.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Missing from associated official evidence: action.
Undeclared colors: Yellow#5, and Yellow#6.
Missing from associated official evidence: action.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC o...
Missing from associated official evidence: action, consumer scope.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on t...
Missing from associated official evidence: action, consumer scope.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Missing from associated official evidence: action, consumer scope.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Missing from associated official evidence: action, consumer scope.
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insul...
Missing from associated official evidence: action, consumer scope.
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
Missing from associated official evidence: action.
Presence of Particulate Matter: Hair was found in products
Missing from associated official evidence: action.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Missing from associated official evidence: action, consumer scope.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Missing from associated official evidence: action, consumer scope.
Moringa Powder ingredient positive for salmonella
Missing from associated official evidence: action.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Missing from associated official evidence: action, consumer scope.
Due to manufacturing issues, reperfusion catheters may fractures
Missing from associated official evidence: action.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Missing from associated official evidence: action, consumer scope.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Missing from associated official evidence: action.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, a...
Missing from associated official evidence: action.
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Missing from associated official evidence: action, consumer scope.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when r...
Missing from associated official evidence: action, consumer scope.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
Missing from associated official evidence: action, consumer scope.
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause...
Missing from associated official evidence: action, consumer scope.
Unapproved food additive: sassafras bark.
Missing from associated official evidence: action.
