2018 Product Recalls

5,529 recalls issued in 2018.

5,529
Total Recalls
133
USDA
258
CPSC
1,426
FDA Drug
USDA 133 CPSC 258 FDA Drug 1,426 FDA Device 773 NHTSA 981 FDA Food 1,958

Showing 41–60 of 5,529 recalls

FDA Class I

Best Taste Brand DRIED BAMBOO SHOOT Mang Non. The product comes in a 12 ounce (340g) uncoded flexible plastic package with UPC: 6 9709 999 40196. Product of P.R.C.

Product contains undeclared sulfites (75 mg per serving).

FDA Class I

Tahini sold under the following brand names: Baron's Tahini double pack, 454g, UPC: X000EZ2HCB; Galil whole tahini, 500g, UPC: 814968020037

Product may be contaminated with Salmonella.

FDA Class II

ASK Foods Inc. Naturally Creative, Roasted Corn and Edamame Salad, 4 lb. Bulk Container sold from the deli

Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.

FDA Class I

Kwik Trip Granola, Bulk Granola, 09976. Net Wt 20 lbs / 9.1 kg. Manufactured by: Oakhouse Bakery, 2221 Mustang Way, Madison, WI 53718.

Bulk Granola may contain undeclared tree nuts (specifically cashew and almond)

FDA Class I

Seasoned Tahini sold under the following brand name: Galil Seasoned Tahini, 500g, UPC: 814968020020

Product may be contaminated with Salmonella.

FDA Class I

Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3

Product contains Lobster, Shrimp, and Soy which are not included on the label.

FDA Class II

Luckyberry Cold-Pressed Juice, Clean & Clear, Pineapple, Green Apple, Cucumber, Min, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS

The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations

FDA Class I

Inspired Organic Sunflower Butter 16oz. plastic jar, 6 per case UPC #: 863669742526 refrigerate after opening

Product testing returned positive test results for Listeria monocytogenes.

FDA Class II

ASK Foods Inc. Smokey Mozzarella Pasta Salad, 4 lb. Bulk Container sold from the deli and to food service accounts

Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.

FDA Class II

Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Frozen (0F or below) FARMED COHO SALMON 10 oz (283g) 2 X 5 oz portions.

Product tested positive for Listeria monocytogenes.

FDA Class I

Sprout Creek Farm Kinkead raw cows' milk cheese semi-firm savory brothy. The product is packaged with an orange label.

Product may be contaminated with Listeria monocytogenes.

FDA Class II

Luckyberry Cold-Pressed Juice, Mai Tai, Orange Pineapple, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS

The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations

FDA Class II

Luckyberry Cold-Pressed Juice, Spicy Watermelon, Watermelon, Red Beet, Lime, Mint, Green Apple, Jalepeno, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS

The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations

FDA Class II

Luckyberry Cold-Pressed Juice, Beetnik, Orange, Red Beet, Kale, Cucumber, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS

The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations

FDA Class I

Kitchen Cravings Mixed Berry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawberries & Blueberries with Sweetened Granola. Keep Refrigerated. UPC 39779-18436. Produced and Distributed by Kwik Trip, Inc., La Crosse, WI 54603

Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup may contain undeclared traces of tree nuts(specifically almond and cashew).

FDA Class II

Luckyberry Cold-Pressed Juice, Seasonal Blend, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS

The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations

FDA

Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

An Urgent Medical Device Recall Letter was sent to customers on 5/31/16 to inform them that BD had identified an issue with the Alaris System PC unit model 8015 with software versions 9.17 and 9.19. Firm has received reports that a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. The letter informs the customers of the potential risk and the required action for users. Customers are informed that BD will contact them within 60 days to initiate the scheduling process for the software upgrade installation.

FDA

GEM Coupler Forceps, GEM4183C, packaged individually.

Potential presence of rust on Coupler Forceps (GEM4183C).

Synovis Micro Companies Alliance (MCS), Inc. a subsidiary of Baxter International Inc., notified customers on about 11/02/2018 via "Urgent Product Recall letter sent via U.S.P.S., first class mail. Instructions included to review inventory for affected product, arrange for return of all affected product to Synovis MCA, complete and return the provided Baxter customer reply form, and notify customers if the affected product was further distributed. General questions can be directed to Synovia MCA at 800-510-3318 or 205-941-0111 Monday through Friday, between 8:00 am and 5:00 pm Central Time.

FDA

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

On 10/3/2018, the firm sent an URGENT FIELD SAFETY NOTIFICATION to customers and distributors via email and/or US Postal Service First Class to inform them of reports of occurrences in which insulin pumps with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of the personal setting, or it could make no sound. Either of these occurrences could cause the user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. Consignees are being informed that they are receiving this letter because the firm's records indicate they may have one of the potentially affected insulin pumps. The notification further explains, this issue occurs when a specific electronic component in the pump malfunctions. This potential loss of audio could delay the user's response to the underlying reason for the alert, alarm, or siren, which could then lead to possible health and safety risks such as hypoglycemia or hyperglycemia. If this issue occurs with the pump, the audio cannot be permanently repaired or regained. The only way to permanently regain the audio capabilities is to exchange the affected pump with a replacement. Even if the pump has the audio issue, it will continue to deliver insulin as expected. Loss of the Vibrate feature has not been reported to occur as part of the above audio failure mode. If a customer has a pump that contains the specific electronic component, and the pump passes the Audio Beep test described below, there is still a chance that the pump may lose its audio capabilities at some future date. Customers are instructed to: What you should do: 1. If you have not already done so, enable the Vibrate feature on your pump. Even if the Audio Beep test passes, you should enable the Vibrate feature (in addition to your Audio feature) since it will add

USDA Class I

Jennie-O Turkey Store Sales, Inc. Recalls Raw Ground Turkey Products due to Possible Salmonella Reading Contamination

Product Contamination