The Recall Desk

Archive

November 2021 recalls

576 recalls were announced in November 2021.

What the numbers show

Critical
2
Severe
243
High
254
Moderate
71
Low
6

Of the 576 recalls this month scored against our rubric, 0% are Critical, 42% are Severe.

1–100 of 576

  • SevereNHTSA·21T018000·2021-11-30

    Sailun Recalls Specific Tires Due to Belt Separation Risk

    Sailun is recalling specific ST235/80R16 and ST235/85R16 tires due to a manufacturing issue that may cause belt separation. This defect could lead to loss of vehicle control and increase crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E097000·2021-11-30

    Tenneco Recalls MOOG and NAPA Tie Rods Due to Heat Treatment Defect

    Tenneco Automotive is recalling specific MOOG and NAPA tie rods that may not have been heat-treated properly. This defect can cause tie rod failure and loss of steering control.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E098000·2021-11-30

    Meritor Recalls 180 Series Drive Pinions Due to Fracture Risk

    Meritor is recalling 180 Series Drive Pinions because they may fracture and engage the parking brake without warning, increasing crash risk.

    Product
    POWER TRAIN:AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V932000·2021-11-29

    Honda Recalls 2016-2020 Models for Hood Latch Striker Defect

    Honda is recalling specific Passport, Pilot, and Ridgeline vehicles because a damaged hood latch striker may cause the hood to open while driving, obstructing the driver's view.

    Product
    HONDA — HONDA RIDGELINE, PILOT, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V931000·2021-11-29

    Mercedes-Benz Recalls EQS and S-Class Models for Infotainment Distraction

    Mercedes-Benz is recalling 2021-2022 EQS and S-Class vehicles because the infotainment system may allow TV and internet use while driving, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580, EQS 450, S 500, S 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V930000·2021-11-26

    Autocar Recalls 2019-2020 Xpeditor Vehicles for Engine Stall Risk

    Autocar is recalling 2019-2020 Xpeditor vehicles with aftermarket power take-off systems because the engine may stall, increasing the risk of a crash.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V929000·2021-11-26

    Nova Bus Recalls 2021 LFS Buses for Door Software Defect

    Nova Bus is recalling 2021 LFS buses because software may cause the rear passenger door to open or close unexpectedly, posing an injury risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V927000·2021-11-25

    Lamborghini Recalls One 2021 Aventador SVJ Roadster for Oil Line Fire Risk

    Lamborghini is recalling one 2021 Aventador SVJ Roadster because improperly tightened oil line screws may detach, causing oil to leak onto hot components and increasing fire risk.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR SVJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0203-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella-Contaminated Onions

    HELLOFRESH US is recalling specific EveryPlate meal kit product codes from production week 08/11/2021 nationwide due to onions contaminated with Salmonella Oranienburg purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 80-82-84-85-88-90-92-99 from Production Week 33 (production week start date: 08/11/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2022·2021-11-24

    Lotrimin AF Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF Deodorant Powder Spray (Miconazole nitrate 2%) nationwide due to the presence of benzene contamination. The recall affects approximately 2.8 million cans distributed across the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2022·2021-11-24

    Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate 1%) spray powder due to the presence of benzene contamination. The recall affects 579,456 cans distributed nationwide.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0177-2022·2021-11-24

    Pier-C Produce White Onions Recalled for Salmonella Contamination

    Pier-C Produce, Inc. is recalling white onions that may be contaminated with Salmonella. The recalled onions were distributed in Florida. Consumers should not eat the affected product.

    Product
    Pier-C Produce, Inc., White Onions Grade No 1, Net Wt 2 lbs (0.907 KG), Distributed by Pier C Produce, Leamington, Ontario, Produce of Mexico
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0192-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling certain meal kits from Production Week 31 (starting 07/28/2021) due to onions contaminated with Salmonella Oranienburg. The affected products were distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-4-5-8-15-19-20-22-24-AA from Production Week 31 (production week start date: 07/28/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0180-2022·2021-11-24

    Red Jumbo Onions Recalled for Potential Salmonella Contamination

    JF Palmer & Sons Produce is recalling 1,040 bags of red jumbo onions due to potential Salmonella contamination. The affected onions were distributed to MN, TX, CA, and MD.

    Product
    Onions Red Jumbo, packaged in 25 pound bulk bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0232-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall

    Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0193-2022·2021-11-24

    HelloFresh Meal Kits Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected product code is 1-2-3-5-9-11-15-17-19-25 from production week starting August 4, 2021.

    Product
    HelloFresh Meal Kit Product Code 1-2-3-5-9-11-15-17-19-25 from Production Week 32 (production week start date: 8/4/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2022·2021-11-24

    Scrip Creme ultrasound lotion recalled for bacterial contamination

    Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.

    Product
    Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0198-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    HELLOFRESH US is recalling specific EveryPlate meal kits from production week 07/07/2021 due to onions contaminated with Salmonella Oranienburg. The affected products were distributed nationwide.

    Product
    EveryPlate Meal Kit Product Codes 82-83-86-88-89-91-92-94-95-96-97-99-100 from Production Week 28 (production week start date: 07/07/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0186-2022·2021-11-24

    Hardies Onion Yellow Jumbo Recalled for Salmonella Contamination Risk

    Hardies Fruit & Vegetable Co., LP is recalling Onion Yellow Jumbo packed in 5-pound boxes due to potential Salmonella contamination. Consumers should not consume the affected product.

    Product
    Onion Yellow Jumbo packed in a 5 pound cardboard box Product Code 2377
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0204-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    EveryPlate meal kits with specific product codes from production week 34 (starting 08/18/2021) are being recalled nationwide because onion ingredients from ProSource are associated with a Salmonella Oranienburg outbreak.

    Product
    EveryPlate Meal Kit Product Codes 82-84-85-87-88-90-92-97-98 from Production Week 34 (production week start date: 08/18/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0242-2022·2021-11-24

    Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to potential benzene contamination. The product was manufactured at a facility where other lots tested positive for benzene.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V923000·2021-11-24

    2022 Ford Super Duty F-250 and F-350 Driver-Side Air Bag Cover Defect Recall

    Ford is recalling 2022 Super Duty F-250 and F-350 vehicles due to an insufficient driver-side air bag cover that may break apart during a crash, projecting fragments toward occupants and increasing injury risk.

    Product
    FORD — FORD F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0175-2022·2021-11-24

    Sysco Onion Products Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling whole yellow and Spanish onions, and pre-cut yellow colossal onions, because they may be contaminated with Salmonella.

    Product
    Whole Yellow and Spanish onions packed in 5 pound bag, 10 pound bag; Pre cut yellow colossal onions
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0209-2022·2021-11-24

    Kroger Garden Salad Recalled Due to Listeria Contamination

    Kroger Garden Salad has been recalled because the Georgia Department of Agriculture detected Listeria monocytogenes in the product. The recall affects specific lot codes distributed to multiple states.

    Product
    Kroger Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 12 oz. (340g) UPC: 0-11110-91036-3 Distributed by The Kroger Company, Cincinnati, OH
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0189-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling meal kits containing onions from ProSource that may be contaminated with Salmonella Oranienburg. The affected product is from Production Week 28 (starting July 7, 2021) and was distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-7-17-19-21-25-AB from Production Week 28 (production week start date: 07/07/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2022·2021-11-24

    Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to the presence of benzene chemical contamination. The recall affects 738,432 cans distributed nationwide and internationally.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0196-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella Oranienburg Contamination

    HelloFresh has recalled meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected products were produced in Week 35 (starting August 25, 2021) and distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 4-12-14-18-23-25-AA from Production Week 35 (production week start date: 8/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0190-2022·2021-11-24

    HelloFresh Meal Kits Recalled for Salmonella Contamination

    HelloFresh is recalling certain meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected kits have Product Codes 2-5-8-9-16-19-21-22-23-24-25 from Production Week 29 (starting July 14, 2021) and were distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-5-8-9-16-19-21-22-23-24-25 from Production Week 29 (production week start date: 07/14/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0182-2022·2021-11-24

    Yellow onions recalled for potential Salmonella contamination

    Brothers Produce of Dallas Inc is recalling 5 lb. boxes of yellow onions due to potential Salmonella contamination. The affected product was distributed in Texas.

    Product
    5 lb. boxes of yellow onions packaged in cardboard boxes
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0174-2022·2021-11-24

    White Onions Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling white onions packed in 10-pound bags due to potential Salmonella contamination. The affected product was distributed across 15 states.

    Product
    White onions packed in 10 pound bag
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0181-2022·2021-11-24

    Raw Onions Recalled Due to Potential Salmonella Contamination

    Bix Produce Company LLC is recalling raw onions in multiple varieties and package sizes due to potential Salmonella contamination. The recall affects products distributed in Iowa, Minnesota, North Dakota, South Dakota, and Wisconsin.

    Product
    Raw onion sold in bags or sliced and diced with the following item numbers and lot code. 1. RED JUMBO 25# 1/25 LB, item 06370; 2. ONIONS,RED JUMBO 1/5 LB, item 06373; 3. ONIONS,RED MEDIUM 1/25 LB, item 06380; 4. ONIONS,WHITE JUMBO 50# 1/50 LB, it
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0199-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    EveryPlate meal kits with product codes 83, 84, 86, 89, 92, 94, and 97 from production week July 14, 2021, are recalled due to onions contaminated with Salmonella Oranienburg. The affected onions were purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 83-84-86-89-92-94-97 from Production Week 29 (production week start date: 07/14/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2022·2021-11-24

    FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination

    Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.

    Product
    Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0208-2022·2021-11-24

    Marketside Garden Salad recalled due to Listeria contamination

    Dole Fresh Vegetables Inc is recalling Marketside Classic Salad (Garden Salad) because samples tested positive for Listeria monocytogenes. The product was distributed to multiple states.

    Product
    Marketside Classic Salad; Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 24 oz. (1 lb. 8 oz.) 680 g UPC: 6-81131-32895-1 Distributed by Walmart, Bentonville, AR
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0248-2022·2021-11-24

    Lotrimin AF Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF miconazole nitrate 2% powder spray due to the presence of benzene chemical contamination. The recall affects approximately 3.8 million cans distributed nationwide.

    Product
    LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0206-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella-Contaminated Onions

    EveryPlate meal kits distributed nationwide are being recalled because they contain onions purchased from ProSource that are associated with a Salmonella Oranienburg outbreak.

    Product
    EveryPlate Meal Kit Product Codes 82-83-89-93-94-96-98 from Production Week 36 (production week start date: 09/01/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0207-2022·2021-11-24

    Dole Garden Salad Recalled for Listeria monocytogenes

    Dole Garden Salad (24 oz) has been recalled because Listeria monocytogenes was detected during testing by the Georgia Department of Agriculture. The affected lots were distributed across ten US states.

    Product
    Dole Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 24 oz. (1 lb. 8 oz.) 680 g UPC: 0 71430 01136 2 Dole Food Company, Inc. Distributed by Dole Fresh Vegetables, Monterey, CA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0176-2022·2021-11-24

    Greenhead Lobster Frozen Cooked Meat Recalled for Listeria Contamination

    Greenhead Lobster brand frozen cooked lobster meat products may be contaminated with Listeria monocytogenes. The recall affects multiple lobster meat products sold in six states.

    Product
    Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 1lb; Greenhead Lobster brand Frozen Cooked Broken Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Tail Meat - 2lbs; Greenhead Lobster brand Fro
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0200-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HelloFresh US is recalling specific EveryPlate meal kits containing onions contaminated with Salmonella Oranienburg. The affected products are from production week starting July 21, 2021, with product codes 84, 88, 89, 90, 91, 92, 94, 98, 99, and 100.

    Product
    EveryPlate Meal Kit Product Codes 84-88-89-90-91-92-94-98-99-100 from Production Week 30 (production week start date: 07/21/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2022·2021-11-24

    LOTRIMIN AF Powder Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray because it was manufactured at a facility where other lots were found contaminated with benzene. The recall affects multiple lot numbers distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2022·2021-11-24

    Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0210-2022·2021-11-24

    Dole Garden Salad Recalled for Listeria monocytogenes

    Dole Fresh Vegetables Inc is recalling Salad Classics Garden Salad (12 oz) due to Listeria monocytogenes contamination found by the Georgia Department of Agriculture. The product was distributed across multiple states.

    Product
    Salad Classics Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 12 oz. (340g) UPC: 6-88267-18443-7 Packaged by Dole Distributed by F-------Old USA, Landover, MD
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0173-2022·2021-11-24

    Red Onions Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling 2,902 cases of red onions packed in 5-pound bags due to potential Salmonella contamination. The onions were distributed to multiple states.

    Product
    Red onions packed in 5 pound bag
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0171-2022·2021-11-24

    Whole White Onions Recalled for Potential Salmonella Contamination

    Keeler Family Farms is recalling whole white onions imported from Chihuahua, Mexico due to potential contamination with Salmonella Oranienburg. The affected onions were shipped between July 1 and August 25, 2021.

    Product
    Whole raw onions - WHITE - imported from Chihuahua, Mexico and shipped from July 1, 2021 through August 25, 2021. Products are packaged in 25 lb. and 50 lb. mesh bags. One pallet contains 42 bags. Store in cool dry place off the ground. Labeling will state product of Mexico on bi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk

    Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2022·2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

    Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2022·2021-11-24

    Tinactin Tolnaftate Powder Spray Recalled Due to Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Powder Spray because some cans contain benzene contamination. Consumers should stop using affected lots and consult a healthcare provider.

    Product
    Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0201-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HELLOFRESH US is recalling specific EveryPlate meal kits containing onions from ProSource linked to a Salmonella Oranienburg outbreak. The affected products were produced in week 31, 2021.

    Product
    EveryPlate Meal Kit Product Codes 82-83-84-90-91-92-94-96-97-100 from Production Week 31 (production week start date: 07/28/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0170-2022·2021-11-24

    Whole Raw Red Onions from Mexico Recalled for Salmonella Risk

    Keeler Family Farms is recalling whole raw red onions imported from Chihuahua, Mexico due to potential contamination with Salmonella Oranienburg. The affected onions were shipped between July 1 and August 25, 2021, and distributed nationwide and to Ontario, Canada.

    Product
    Whole raw onions - RED - imported from Chihuahua, Mexico and shipped from July 1, 2021 through August 25, 2021. Products are packaged in 25 lb. and 50 lb. mesh bags. One pallet contains 42 bags. Store in cool dry place off the ground. Labeling will state product of Mexico on bill
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0247-2022·2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recall for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling LOTRIMIN AF Jock Itch Powder Spray (4.6 oz, Miconazole Nitrate 2%) because certain lots contain benzene, a chemical contaminant.

    Product
    LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0188-2022·2021-11-24

    Fisherman's Wharf Cooked Shrimp Recalled for Listeria Risk

    Fisherman's Wharf Shrimp 16/20 Cooked Shrimp 16oz packages are being recalled due to potential contamination with Listeria monocytogenes. The affected products were distributed domestically with specific serial numbers and best-by dates in early April 2023.

    Product
    Fisherman's Wharf, Shrimp 16 /20 Cooked Shrimp 16oz 7306067
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0202-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    EveryPlate meal kits from production week 08/04/2021 are being recalled because they contain onions contaminated with Salmonella Oranienburg. The onions were purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 81-82-84-90-92-95-98-99 from Production Week 32 (production week start date: 08/04/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2022·2021-11-24

    Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0231-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall

    The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2022·2021-11-24

    Tinactin Tolnaftate Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling Tinactin Tolnaftate 1% Jock Itch Powder Spray due to the presence of benzene contamination. The product was distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0205-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HelloFresh is recalling specific EveryPlate meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. Affected product codes from production week 08/25/2021 are being recalled nationwide.

    Product
    EveryPlate Meal Kit Product Codes 87-88-89-90-91-94-101 from Production Week 35 (production week start date: 08/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0185-2022·2021-11-24

    Red Onions Recalled for Potential Salmonella Contamination

    Hardies Fruit & Vegetable Co., LP is recalling red onions (Jumbo and Medium sizes) due to potential Salmonella contamination. Affected products were distributed in Texas.

    Product
    Onion Red Jumbo packed in a 5 pound cardboard box Product Code 2307, Onion Red Medium packed in a 5 pound cardboard box Product Code 2308
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0184-2022·2021-11-24

    Green Giant Fresh Whole White Onions Recalled for Salmonella

    Green Giant Fresh brand whole white onions in 2 lb. bags are being recalled due to potential Salmonella Oranienburg contamination. The affected onions were distributed in Minnesota and North Dakota.

    Product
    Green Giant Fresh brand, Whole WHITE Onions packaged in 2 lb. flexible mesh bags, UPC 60580600218-2.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0162-2022·2021-11-24

    Carolina Ingredients Jalapeno Seasoning Recalled for Possible Lead

    Carolina Ingredients is recalling Jalapeno Seasoning due to possible lead contamination. The product was distributed to a customer in Georgia.

    Product
    Carolina Ingredients Jalapeno Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0254-2022·2021-11-24

    Out-of-Specification Swabstick Recalled in REGARD Stereotactic Tray

    ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Stereotactic Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0166-2022·2021-11-24

    Sliced Pickled Beets Recalled Due to Lack of Acidulant

    Seneca Foods Corporation is recalling Aunt Nellie's and Happy Harvest sliced pickled beets due to inadequate acidity, which may allow botulism-causing bacteria to grow. The recall affects 15,074 cases distributed across 22 U.S. states.

    Product
    Sliced Pickled Beets, Net Wt 16oz. (1lb) 454g, packaged under the following brands: 1. Aunt Nellie's, UPC 44300-05463, Distributed by Seneca Foods Corp, Marion, NY 14505-0997 2. Happy Harvest, Dist & Sold Exclusively by: Aldi, Batavia, IL 60510
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0165-2022·2021-11-24

    Carolina Ingredients Sweet Chipotle Seasoning Recalled for Possible Lead

    Carolina Ingredients is recalling Sweet Chipotle Seasoning due to possible lead contamination. The product was distributed to one customer in Georgia.

    Product
    Carolina Ingredients Sweet Chipotle Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V926000·2021-11-24

    Alamo Recalls Old Dominion Trailers with Wiring Defect

    Alamo Group is recalling 2019-2021 Old Dominion Brush Co. trailers because incorrect wiring may prevent the emergency brake from engaging if the trailer detaches.

    Product
    OLD DOMINION BRUSH CO. — OLD DOMINION BRUSH CO. TRAILER MOUNT UNIT, TOW BEHIND UNIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2022·2021-11-24

    LEEP PRECISION Integrated System may fail to coagulate during surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.

    Product
    LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2022·2021-11-24

    Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling

    Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0183-2022·2021-11-24

    Green Giant Fresh Whole Yellow Onions Recalled for Salmonella

    Potandon Produce LLC is recalling Green Giant Fresh brand whole yellow onions in 2 lb., 3 lb., and 5 lb. bags due to potential Salmonella Oranienburg contamination. The affected products were distributed in Minnesota and North Dakota.

    Product
    Green Giant Fresh brand, Whole YELLOW Onions packaged in 2 lb. flexible mesh bags, UPC 60580600120-8. Green Giant Fresh brand, Whole YELLOW Onions packaged in 3 lb. flexible mesh bags, UPC 60580600123-9. Green Giant Fresh brand, Whole YELLOW Onions packaged in 5 lb. flexible mesh
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0253-2022·2021-11-24

    REGARD Newborn Tray Recalled Due to Out-of-Spec Antiseptic Component

    ROi CPS LLC is recalling REGARD Newborn Trays (lot 86453F) distributed in FL, LA, and MO because some units contain a povidone-iodine swabstick component manufactured out of specifications.

    Product
    REGARD Newborn Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V924000·2021-11-24

    Harley-Davidson Recalls 2021 Pan America Motorcycles for Seat Base Defect

    Harley-Davidson is recalling 2,689 2021 Pan America RA1250 motorcycles because the seat base may not be fastened properly, posing an injury risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON PAN AMERICA (RA1250)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0164-2022·2021-11-24

    Carolina Ingredients Smoked Peppered Bacon Seasoning Recalled for Possible Lead

    Carolina Ingredients is recalling its Smoked Peppered Bacon Seasoning due to possible lead contamination. The product was shipped to a customer in Georgia.

    Product
    Carolina Ingredients Smoked Peppered Bacon Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0187-2022·2021-11-24

    Amenity Box Mix Fruits and Vegetables recalled for Salmonella contamination

    Hardies Fruit & Vegetable Co., LP is recalling Amenity Box Mix Fruits and Vegetables due to potential Salmonella contamination. The affected product was distributed in Texas.

    Product
    Amenity Box Mix Fruits and Vegetables packed in 19-20 pound cardboard box Product Code 11303
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0257-2022·2021-11-24

    LEEP PRECISION Electrosurgical System Coagulation Function May Fail

    CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.

    Product
    LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2022·2021-11-24

    HelloFresh Meal Kits Recalled Due to Salmonella-Contaminated Onions

    HelloFresh is recalling meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected products were produced during week 33 in 2021.

    Product
    HelloFresh Meal Kit Product Code 4-6-9-10-11-13-15-20 from Production Week 33 (production week start date: 8/11/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle

    Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.

    Product
    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

    Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

    Product
    bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0221-2022·2021-11-24

    Simply Fresh Salads Cranberry Walnut Salad Recall for Undeclared Wheat

    Five Star Gourmet Foods is recalling Simply Fresh Salads Cranberry Walnut Salad because wheat allergen is not declared on the label, though flatbread chips containing wheat are visible in the package. The product is distributed in WA, AZ, PA, and TX.

    Product
    Simply Fresh Salads - Cranberry Walnut Salad with Very Berry Vinaigrette; sweet-tart cranberries & Walnuts, feta cheese, crunchy flatbread and spring mix. Keep refrigerated. Net Wt. 4.2 oz. (119g) UPC: 8 50012 79394 6 Contains: Milk, treenut (walnut) Distributed by: FiveStar
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0178-2022·2021-11-24

    JF Palmer Yellow Onions Recalled for Potential Salmonella Contamination

    JF Palmer & Sons Produce is recalling approximately 6,970 bags of yellow onions in multiple sizes due to potential Salmonella contamination. The affected onions were distributed in Minnesota, Texas, California, and Maryland.

    Product
    Onions Yellow, Small, Medium, Large, Jumbo, Colossal, Super Colossal packaged in 16.3 pound and 50 pound bulk bags
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0223-2022·2021-11-24

    Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk

    Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.

    Product
    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2022·2021-11-24

    Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure

    CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0197-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella Contamination in Onions

    HelloFresh is recalling meal kits with product code 8-15-19-24 from production week 36 (starting September 1, 2021) nationwide because the onions used contain Salmonella Oranienburg.

    Product
    HelloFresh Meal Kit Product Code 8-15-19-24 from Production Week 36 (production week start date: 09/01/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0191-2022·2021-11-24

    HelloFresh Meal Kit Products Recalled for Salmonella Contamination

    HelloFresh is recalling specific meal kit products containing onions from ProSource linked to a Salmonella Oranienburg outbreak. The affected products were distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-3-8-10-15-18-19-22-23 from Production Week 30 (production week start date: 07/21/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2022·2021-11-24

    Sensis Diagnostic System UI Freeze Risk Without Regular System Reboots

    Siemens' Sensis diagnostic systems may experience partial UI freezing and fail to update vital signs display if not rebooted at least every 7 days per manufacturer instructions.

    Product
    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology stud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation

    Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.

    Product
    SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0241-2022·2021-11-24

    Lotrimin AF Liquid Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF Miconazole nitrate 2% Liquid Spray nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to contain benzene.

    Product
    Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0250-2022·2021-11-24

    REGARD Basic Cataract Tray Recalled for Out-of-Specification Component

    ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Basic Cataract tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2022·2021-11-24

    LEEP PRECISION Surgical Generator May Fail to Coagulate During Surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Generator 220V because the coagulation hand switch may fail, potentially causing uncontrolled bleeding during surgery.

    Product
    LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2022·2021-11-24

    Electrosurgical Generator Coagulation Function May Fail During Surgery

    CooperSurgical recalled 700 Quantum 2000 Electrosurgical Generators due to a hand switch coagulation function defect that may fail to operate during surgery, potentially requiring medical intervention to control intraoperative bleeding.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V925000·2021-11-24

    RAM Pickup Trucks Side Air Bag Deployment Defect Recall

    Chrysler is recalling certain 2021-2022 RAM 2500 and 3500 pickup trucks and 2021 RAM 1500 Classic models. The side air bag curtain assemblies may deploy improperly due to incorrect gas pressure, increasing injury risk in a crash.

    Product
    RAM — RAM 2500, 3500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2022·2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2022·2021-11-24

    REGARD Ear Tray recalled due to out-of-spec swabstick component

    ROi CPS LLC is recalling the REGARD Ear Tray because it contains a Povidone-Iodine swabstick component that does not meet specifications. The product was distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ear Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0195-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella Contamination in Onions

    HelloFresh is recalling meal kits from production week starting 8/18/2021 due to onions contaminated with Salmonella Oranienburg. The onions were purchased from ProSource and distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-3-6-8-10-14-16-22-23-24 from Production Week 34 (production week start date: 8/18/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System recalled for potential tip separation

    Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.

    Product
    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0240-2022·2021-11-24

    Lotrimin Daily Prevention Deo Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was distributed nationwide and internationally.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2022·2021-11-24

    Bodycad Torque Limiting Adaptor Recalled for Breakage Risk

    Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.

    Product
    Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0161-2022·2021-11-24

    Carolina Ingredients Avocado Lime Seasoning recalled for possible lead

    Carolina Ingredients is recalling its Avocado Lime Seasoning due to possible lead contamination. The firm was notified by a customer and sent samples to a lab for testing.

    Product
    Carolina Ingredients Avocado Lime Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0160-2022·2021-11-24

    Carolina Ingredients Beef Gravy Mix Recalled for Elevated Lead Levels

    Carolina Ingredients is recalling Beef Gravy Mix (product code N715025) due to elevated lead levels found in some samples after lab testing. All affected product was shipped to a customer in Georgia.

    Product
    Carolina Ingredients Beef Gravy Mix Non-allergen N715025 Net Wt. 50 lbs. Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0179-2022·2021-11-24

    White Onions Recalled Due to Potential Salmonella Contamination

    JF Palmer & Sons Produce is recalling white onions packaged in 50-pound bulk bags due to potential Salmonella contamination. The recall affects onions distributed to Minnesota, Texas, California, and Maryland.

    Product
    Onions White, Medium, Large, Jumbo, packaged in 50 pound bulk bags
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0239-2022·2021-11-24

    Lotrimin Daily Prevention Deo recalled for potential benzene contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found contaminated with benzene.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide

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