2021 Product Recalls
4,623 recalls issued in 2021.
Showing 101–120 of 4,623 recalls
Mother's Milk Bank of North Texas 817-810-0071 Pasteurized Donor Human milk Volume: 100mL 1.00 g/dL Protein packaged in sterile BPA free plastic bottle
Foreign object found in bottle
Yeast Extract Ajirex in 15 kg PE bag in carton box
Potential Salmonella contamination.
Tang guava pineapple drink mix powder 18 oz. UPC 043000064511
potential for glass and metal in product
The Mustard Man Inc Simply Peppered Mustard 8oz plastic bottles, 6 bottles per case
Wrong Product in packaging - Simply Peppered Mustard bottles were filled with Simply Horsey Mustard
Country Time Pink Lemonade powder drink mix 19 oz. UPC 043000951149 63 oz. UPC 043000082188 82.5 oz. UPC 043000928615
potential for glass and metal in product
Country Time Half lemonade and Half iced tea drink mix powder 19 oz. UPC 043000046005 82.5 oz. UPC 043000046012
potential for glass and metal in product
Kool-Aid Tropical Punch powder drink mix 19 oz. UPC 043000953501 63 oz. UPC 043000953501 82.5 oz. UPC 043000957400
potential for glass and metal in product
Arizona Arnold Palmer Half Iced Tea & Half Lemonade drink mix powder 73 oz. UPC 043000086643
potential for glass and metal in product
Kool-Aid ice blue raspberry lemonade drink mix powder 20 oz. UPC 043000954072
potential for glass and metal in product
Country Time Original Lemonade drink mix powder 2.4 KG UPC 661880533800
potential for glass and metal in product
Kool-Aid strawberry drink mix powder 19 oz. UPC 043000953556
potential for glass and metal in product
Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in each nostril as needed - 103 times daily as needed. Children 3 and under: It is always advised to consult with a pediatrician or healthcare provided before use.. Ingredients: Proprietary probiotic blend in an enzyme enriched substrate. Made from water and a proprietary blend of three organic gr
Probiotic products contaminated with Pseudomonas aeruginosa .
Country Time "on the go" Lemonade 10 pack net wt. 6.7 oz. drink mix powder UPC 043000010983
potential for glass and metal in product
Morton Iodized Salt, Net Wt. 26 oz (1 LB 10 OZ) 737 g, Morton Salt, Inc. Chicago, IL 60606
Product labeled to contain iodized salt actually contain salt not fortified with iodine.
Al Kanater Tahini Sesame Seeds. 1 Lb plastic bottle. UPC 6-92551-00002-0
potential contamination with Salmonella
Kool-Aid Tropical Punch "on the go" 10 pack net wt. 6.6 oz. drink mix powder UPC 043000023464
potential for glass and metal in product
Ripple Dairy-Free. As It Should Be 8g Plant Based Protein; Half the Sugar of Dairy Milk PET bottle with twist cap 50% More Calcium that Dairy Milk. Keep refrigerated. Fresh for 7-10 days after opening. 48 fl oz. (1.5 qt) ((1.42L) - 6 x 48 ox. bottles per case Ingredients: Water, Pea Protein blend, (water, pea protein) cane Sugar, Sunflower oil. Contains less than 1% of Vitamin A Palmitate, Vitamin D2, Vitamin B12, Tricalcium Phosphate, Sunflower lecithin, Natural Flavor, Seal salt, guar, Gell
Complaint led investigation found the presence of Bacillus Cereus in one lot of product.
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.
On 11/11/21, correction notices were distributed to healthcare professionals. The recalling firm will provide a warning and instructional placard to be applied to impacted systems. Customers with questions are encouraged to call Technical Services for help at: 1-888-826-5603. Customers are asked to complete and return the confirmation form and maintain a copy of this correction notice. Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring: Firm recommends NOT turning off Guidance View after locking the biopsy trajectory in the Cranial software. After locking trajectory for biopsy needle navigation, always ensure Guidance View remains an active view in at least one screen layout quadrant. If a discrepancy is detected between the biopsy depth gauge graphic and the other 2D information: 1) Obstruct the camera field of view of the biopsy needle or reference frame to cause red status. 2) Return to green status by no longer obstructing camera field of view of the biopsy needle and reference frame. 3) Use the Cycle Views icon to refresh guidance view and confirm that the biopsy depth gauge graphic matches the distance to target values and the position to target information provided by the 2D crosshairs. 4) Visually confirm accuracy before proceeding with navigation. Always Visually confirm navigational accuracy and confirm that the biopsy depth gauge graphic matches the distance to target values and matches the position to target information provided by the 2D crosshairs, which represent the tip position of the navigated instrument. Use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
On October 13, 2021, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed that the needles may contain black debris on the exterior of the inner stylet and/or the interior of the outer cannula. Potential adverse events that may occur if an affected product is used include local/self-limited inflammatory reactions. To date, Cook has received no complaints related to this issue. However, please be advised that the presence of black debris may go undetected by the user. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Action being Taken by Cook Medical Cook Medical is removing potentially impacted devices from the market. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue. If you have any questions or concerns, please contact Cook Medi
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
On 11/12/21, recall notices were sent to OR Directors, Risk Managers, or Material Managers. Customers were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3) If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4) Complete the Business Reply Form and return to acclarent8930@sedgwick.com 5) After the Business reply Form is received a return kit will be sent. 6) Keep this notice visibly posted for awareness until all product subject to this recall has been returned. Customers with additional questions are encouraged to call the recalling firm at 1-877-775-2789, 4:00am-5:00pm PST.