The Recall Desk

Archive

September 2019 recalls

454 recalls were announced in September 2019.

What the numbers show

Critical
36
Severe
124
High
216
Moderate
64
Low
14

Of the 454 recalls this month scored against our rubric, 8% are Critical, 27% are Severe.

201–300 of 454

  • HighFDA (Food)·F-2246-2019·2019-09-18

    YoCrunch Vanilla Yogurt Recalled for Undeclared Peanuts and Eggs

    Danone Waters of America is recalling YoCrunch Vanilla Lowfat Yogurt with Snickers Pieces due to an incorrect overwrap that results in undeclared peanuts and eggs.

    Product
    YoCrunch VANILLA LOWFAT YOGURT WITH SNICKERS PIECES 4 - 4 oz (113g) - 16 oz (453g) 6 packaged or 4 cups per case. UPC 46675 01326
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2496-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2142-2019·2019-09-18

    Bubbies and Trader Joe's Mochi Ice Cream Recalled for Plastic Pieces

    Bubbies and Trader Joe's are recalling specific mochi ice cream products due to the potential for free-floating foreign plastic pieces.

    Product
    Trader Joes - Vanilla Item Code 64500, UPC Code 00645003. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2019·2019-09-18

    Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is recalling Sheridan/CF Novaplus 7.0 mm tracheal tubes because the Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2019·2019-09-18

    Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue

    Zimmer Biomet is recalling 50 units of the XP-XP Tibial Tray - Interlok 59 mm because the locking bar may not fully engage.

    Product
    XP-XP Tibial Tray - Interlok 59 mm Item # 195750
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2540-2019·2019-09-18

    Stryker Recalls Berchtold Chromophare F628 Surgical Lights Due to Assembly Defect

    Stryker is recalling 3,344 Berchtold Chromophare F628 surgical lights because the back cover of the light head was insufficiently assembled and could fall off.

    Product
    Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2020·2019-09-18

    QQ Fish Crab Flavored Seafood Ball Recalled for Undeclared Egg

    Great One Trading Inc. is recalling QQ Fish brand Crab Flavored Seafood Ball because it contains undeclared egg, a major allergen not listed on the label.

    Product
    QQ Fish brand CRAB FLAVOURED SEAFOOD BALL; Net weight 200g/7oz
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2122-2019·2019-09-18

    Bubbies Ice Cream Products Recalled for Potential Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and Cookie Dough Ice Cream Bites due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Cookie Dough Ice Cream Bites - Brownie Batter, Item Code CDR00003, UPC 50012-4, UPC GTIN 10787325500121. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2149-2019·2019-09-18

    Bakkavor USA Recalls Savory Tuna Salad Due to Undeclared Shrimp

    Bakkavor USA is recalling 16-ounce Savory Tuna Salad containers distributed in Texas because the product contains undeclared shrimp.

    Product
    Savory Tuna salad 16 oz. packaged in Clear PP containers UPC 4122033749
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2141-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and Cookie Dough Ice Cream Bites due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream Strawberry, Triple Chocolate Item Code CS1601412, UPC Code 40015-8, UPC GTIN 10787325400155 Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0007-2020·2019-09-18

    QQ Fish Cuttlefish Flavored Seafood Balls Recalled for Undeclared Egg

    Great One Trading Inc. is recalling QQ Fish brand Cuttlefish Flavored Seafood Balls because the product contains an undeclared allergen, specifically egg.

    Product
    QQ Fish brand CUTTLEFISH FLAVOURED SEAFOOD BALL; Net weight 200g/7oz
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2251-2019·2019-09-18

    High Liner Recalls Sea Cuisine Asian Grill Rubbed Salmon for Listeria Risk

    High Liner Foods Inc. is recalling Sea Cuisine Asian Grill Rubbed Salmon fillets potentially contaminated with Listeria monocytogenes. The product was distributed in Massachusetts and Missouri.

    Product
    Sea Cuisine Asian Grill Rubbed Salmon. Two Atlantic Salmon fillets with garlic, ginger, soy sauce & chiles; NET WT 8 OZ (227 g); KEEP FROZEN; Cooking instructions included - " be sure to cook to a minimum temperature of 165F before enjoying"
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2519-2019·2019-09-18

    Zimmer Biomet Recalls XP-XP Tibial Trays Due to Locking Bar Defect

    Zimmer Biomet is recalling specific XP-XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and several international regions.

    Product
    XP-XP Tibial Tray - Interlok 79 mm Item # 195758
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2464-2019·2019-09-18

    Allergan Textured Breast Implants Recalled Due to Lymphoma Risk

    Allergan is recalling textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2019·2019-09-18

    Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect

    Zimmer Biomet is recalling 375 units of the XP-CR Tibial Tray - Interlok 65mm because the locking bar may not fully engage.

    Product
    XP-CR Tibial Tray - Interlok 65mm Item # 195270
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2311-2019·2019-09-18

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2019·2019-09-18

    Teleflex Recalls Sheridan/HVT Novaplus Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan/HVT Novaplus tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2124-2019·2019-09-18

    Bubbies Ice Cream Products Recalled for Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and Cookie Dough Ice Cream Bites due to potential foreign plastic pieces.

    Product
    Bubbies Cookie Dough Ice Cream Bites -Sugar Cookie Item Code CDR00004, UPC Code 50014-8, UPC GTIN 10787325500145. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2019·2019-09-18

    Teleflex Recalls Sheridan EZ-ENDO Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan EZ-ENDO tracheal tubes because the 15 mm connector may disconnect, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1853-2019·2019-09-18

    FDA Recalls Compounded Acetyl-L-Cysteine Ophthalmic Solution Due to Processing Controls

    Compounded Solutions in Pharmacy is recalling 20% Acetyl-L-Cysteine Ophthalmic Solutions because of a lack of processing controls. The product was dispensed to patients in 3ml dropper bottles.

    Product
    20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-2134-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies Mochi Ice Cream is being recalled due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -Passion Fruit Item Code CS800119, UPC Code 20093-2, UPC GTIN 10787325200939. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2019·2019-09-18

    Allergan Recalls Textured Silicone-Filled Breast Implants Due to Lymphoma Risk

    Allergan PLC is recalling specific textured silicone-filled breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2127-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies Mochi Ice Cream is being recalled due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -Chocolate Espresso Item Code CS812079, UPC Code 20053-6, UPC GTIN 10787325200533. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2019·2019-09-18

    Teleflex Recalls Hudson RCI Sheridan Uncuffed Tracheal Tubes

    Teleflex Medical is recalling Hudson RCI Sheridan Uncuffed tracheal tubes because specific lots of the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2019·2019-09-18

    Teleflex Medical Recalls Hudson RCI Sheridan/HVT Tracheal Tubes

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan/HVT tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2143-2019·2019-09-18

    Bubbies and Trader Joe's Mochi Ice Cream Recalled for Plastic Pieces

    Bubbies and Trader Joe's are recalling specific mochi ice cream products due to the potential for free-floating foreign plastic pieces.

    Product
    Trader Joes - Green Tea Item Code 64669, UPC Code 00645003. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2019·2019-09-18

    Zeus Scientific Recalls Dynex DSX Software for False Negative ELISA Results

    Zeus Scientific is recalling 28 Dynex DSX software files due to a programming error that causes false negative results in specific ELISA assays.

    Product
    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling 4 million textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.

    Product
    Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V666000·2019-09-18

    Mercedes-Benz Recalls 2019 Metris Vehicles Due to Head Restraint Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz Metris vehicles because head restraint spring pins may be missing or improperly mounted, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2154-2019·2019-09-18

    Cena Vegan Pollo Asado Recalled for Undeclared Soy Allergen

    Cena Vegan is recalling Pollo Asado plant-based meat because an inspection found undeclared hydrolyzed soy protein, a major allergen.

    Product
    Cena Vegan Pollo Asado Plant-Based Meat; Net Wt. 16 oz. (448 grams) retail, Net Wt. 5 lb. - food service; UPC: 8 55687 00701 5; Ingredient: Vital wheat gluten, Garbanzo bean flour, Vegetable bouillon, Orange juice, Less than 2% of: Vegetable Oil, Lime Juice, Onion Powder,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2133-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Foreign Plastic Pieces

    Bubbies Mochi Ice Cream is being recalled due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -Mango Item Code CS800037, UPC Code 20063-5, UPC GTIN 10787325200632. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2121-2019·2019-09-18

    Martha White Gluten Free Cornbread Mix Recalled for Gluten Presence

    Hometown Food Company is recalling Martha White Gluten Free Sweet Yellow Cornbread & Muffin Mix because the product tested positive for gluten despite being labeled gluten-free.

    Product
    Martha White Gluten Free Sweet Yellow Cornbread & Muffin Mix packaged in a 7oz. pouch. 12 pouches per wholesale case. Item UPC: 0 1330082014 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0006-2020·2019-09-18

    QQ Fish Seafood Balls Recalled for Undeclared Egg Allergen

    Great One Trading Inc. is recalling QQ Fish brand Shrimp Flavoured Seafood Balls because they contain an undeclared egg allergen.

    Product
    QQ Fish brand SHRIMP FLAVOURED SEAFOOD BALL; Net weight 200g/7oz
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2132-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Foreign Plastic Pieces

    Bubbies Mochi Ice Cream is being recalled due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -lychee Item Code CS800001, UPC Code 20033-8, UPC GTIN 10787325200335. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2130-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and related products due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -Green Tea Item Code CS800056, UPC Code 20023-9, UPC GTIN 10787325200236. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2140-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and related products due to the potential for free-floating foreign plastic pieces.

    Product
    Bubbies Mochi Ice Cream Premium Variety Pack (Strawberry, Green Tea, Mango) Item Code CS1600001, UPC Code 40013-4, UPC GTIN 10787325400131 Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2019·2019-09-18

    Zimmer Biomet Recalls Vanguard XP Tibial Trays Due to Locking Bar Issue

    Zimmer Biomet is recalling Vanguard XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and internationally.

    Product
    Vanguard XP Tibial Tray 71 mm Item # 195249
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-2538-2019·2019-09-18

    Smith & Nephew Recalls Legion Hemi Step Tibial Wedge Due to Packaging Error

    Smith & Nephew is recalling 12 units of Legion Hemi Step Tibial Wedges because they were inadvertently packaged with an incorrect screw component.

    Product
    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2144-2019·2019-09-18

    Calcium Supplement Recalled for Lacking Declared Vitamin D Content

    Jivan Shakti Inc. is recalling 790 bottles of Dr. Naram's Rasayana D Tablet because FDA testing found no Vitamin D in the product.

    Product
    Plastic Bottles labeled with: "Ancient Youth Secret - Since 500 B.C., DR. NARAM'S RASAYANA D TABLET, Calcium Supplement with Vitamin D*, Dietary Supplement, 60 Tablets, FOR EXPORT ONLY, Imported & Distributed by: Jivan Shakti INC, 933 South Street, Peekskill, NY 10566, Manufactur
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-1851-2019·2019-09-18

    Macleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency

    Macleods Pharma USA is recalling Pramipexole Dihydrochloride Tablets 0.125 mg because stability studies showed the drug was subpotent.

    Product
    PRAMIPEXOLE DIHYDROCHLORIDE — PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2148-2019·2019-09-18

    Chicken of the Sea Salmon Pouches Recalled for Microbial Spoilage

    Tri-Union Frozen Products is recalling specific Chicken of the Sea salmon pouches due to microbial activity causing bloating. The product was distributed in four states.

    Product
    Lemon Chive Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 and 0 480000 11817 7 individual pouch; UPC 1 00 48000 01179 1 - Case Chicken of the Sea International El Segundo, CA Product of Thail
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2499-2019·2019-09-18

    Exactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism

    Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.

    Product
    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2495-2019·2019-09-18

    Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue

    Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.

    Product
    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2150-2019·2019-09-18

    Ruiz Food Products Recalls El Monterey Bean and Cheese Burritos

    Ruiz Food Products is recalling El Monterey XXL Bean and Cheese Burritos due to two complaints of foreign objects in the frozen product.

    Product
    El Monterey XXL Bean and Cheese Burrito; 9.5 oz. frozen burrito in film Microwaveable Case UPC: UPC 1 00 71007 06217 6; Sell unit UPC: 0 71007 06217 9
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2147-2019·2019-09-18

    Cracked Pepper Chicken of the Sea Salmon Recalled for Bloating

    Tri-Union Frozen Products is recalling Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon pouches due to microbial spoilage causing bloating.

    Product
    Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 and 0 480000 11817 7 individual pouch; UPC 1 00 48000 01179 1 - Case Chicken of the Sea International El Segundo, CA Product of Th
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2151-2019·2019-09-18

    FungusAmongUs Shiitake Organic Mushrooms Recalled for Undeclared Sulfites

    Seattle Gourmet Foods Inc. is recalling FungusAmongUs Shiitake Organic Mushrooms due to undeclared sulfites detected by the Florida Department of Agriculture.

    Product
    FungusAmongUs Shiitake Organic Mushrooms are dried mushrooms. Packaged in a clear cellophane bag, net Weight 1 ounce. UPC 7 19870 60023 3 for individual 1 ounce bags UPC 50719870600016 for Master caddy that holds 8 packages of 1 ounce bags The label is read in parts: "***O
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2153-2019·2019-09-18

    Abbott Recalls Similac Pro-Sensitive Bottles Due to Packaging Error

    Abbott Nutrition is recalling specific cartons of Similac Pro-Sensitive that may contain Similac Pro-Advance bottles due to a packaging error.

    Product
    Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2488-2019·2019-09-18

    Philips Recalls Two HeartStart MRx Monitor/Defibrillators for Missing Corrections

    Philips North America, LLC is recalling two HeartStart MRx Monitor/Defibrillators because they may not have received applicable corrections from prior field actions.

    Product
    HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1855-2019·2019-09-18

    Compounded Acetyl-L-Cysteine Eye Drops Recalled for Processing Control Issues

    Compounded Solutions in Pharmacy is recalling 5% Acetyl-L-Cysteine Ophthalmic Solutions due to a lack of processing controls. The product was dispensed to patients in 5ml and 10ml dropper bottles.

    Product
    5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2152-2019·2019-09-18

    Stonyfield Kids Strawberry Beet Berry Tubes Recalled for Misbranding

    Stonyfield Farm is recalling 4,064 cartons of Kids Strawberry Beet Berry Tubes because the outer carton labeling does not match the product.

    Product
    Stonyfield Kids Strawberry Beet Berry Tubes, 8 count-2oz each; 453g/package; Keep Refrigerated
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-1848-2019·2019-09-18

    Mylan Recalls Gatifloxacin Ophthalmic Solution Due to Unknown Impurity

    Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1847-2019·2019-09-18

    Lamivudine Tablets Recalled for Incorrect Package Insert Labeling

    American Health Packaging is recalling Lamivudine Tablets due to an error in the package insert that incorrectly lists tablet description coding.

    Product
    Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2492-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

    Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.

    Product
    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2490-2019·2019-09-18

    Randox Calibration Serum Recalled for Incorrect Analyte Targets

    Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.

    Product
    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2493-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

    Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify tether removal during implant.

    Product
    Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19V658000·2019-09-17

    Hyundai Translead Recalls 2017-2018 Duralite HT Flatbed Trailers

    Hyundai Translead is recalling 2017-2018 Duralite HT flatbed trailers because bulkhead brackets may break, causing the bulkhead to detach and create a road hazard.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD DURALITE HT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V656000·2019-09-17

    McNeilus CNG Trucks Recalled for Pressure Relief Device Defect

    McNeilus is recalling 330 CNG-powered trucks from 2013-2018 because pressure relief devices may fail to vent pressure, increasing the risk of tank explosion, fire, and injury.

    Product
    MCNEILUS — MCNEILUS AUTOREACH, STANDARD MIXER, ZERO RADIUS, ATLANTIC FRONT LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·092-2019·2019-09-17

    Perdue Recalls Frozen Chicken Tenders for Undeclared Wheat Allergen

    Perdue Foods is recalling approximately 495 pounds of frozen chicken breast tenders because they contain undeclared wheat and are mislabeled as gluten-free.

    Product
    Perdue Foods LLC — Perdue Foods LLC Recalls Simply Smart Organics Frozen Chicken Ready-to-Eat Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·19V659000·2019-09-17

    Terex TLM Aerial Vehicles Recalled for Boom Valve Defect

    Terex is recalling 2016-2017 TLM aerial devices because an incorrect holding valve may cause the boom to drift down if a hose bursts.

    Product
    TEREX — TEREX TLM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V655000·2019-09-16

    Airstream Recalls 2016-2017 Trailers Due to Electrical Fire Risk

    Airstream is recalling specific 2016-2017 Flying Cloud and International trailers because an inverter may contact a fuse, creating a fire hazard.

    Product
    AIRSTREAM — AIRSTREAM FLYING CLOUD, INTERNATIONAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E062000·2019-09-12

    Chrysler Recalls Mopar Passenger Air Bag Modules Due to Testing Defect

    Chrysler is recalling specific Mopar replacement passenger air bag modules that did not complete developmental testing. These modules may not perform as designed in a crash, increasing injury risk.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V654000·2019-09-12

    Nissan and Infiniti Recall Vehicles for Backup Camera Display Defect

    Nissan is recalling 2018-2019 Nissan and Infiniti vehicles because backup camera settings can be adjusted to hide the rear view image, increasing crash risk.

    Product
    NISSAN — NISSAN, INFINITI ROGUE SPORT, ARMADA, VERSA, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2097-2019·2019-09-11

    Mountain Mel's Peaceful Baby Herbal Tea Recalled for Salmonella Risk

    Mountain Mel's Essential Goods LLC is recalling Peaceful Baby For Colic & Teething Discomfort Herbal Tea due to potential Salmonella contamination.

    Product
    Peaceful Baby For Colic & Teething Discomfort Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05656 0 The label is read in parts: "***Peaceful Baby FOR COLIC & TEETHING DISCOMFORT ***CAFFEINE-FREE HERBAL TEA*** Mountain Mels Essen
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2481-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure

    OMNIlife science Inc. is recalling six ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2446-2019·2019-09-11

    Stryker Recalls Berchtold Chromophare Monitor Carrier Arms Due to Weld Defects

    Stryker Communications is recalling 52 Berchtold Chromophare Dual Monitor Carrier Arms or Dual Flat Panels because the mounts may have insufficient welds.

    Product
    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-2098-2019·2019-09-11

    Mountain Mel's Herbal Tea Recalled for Potential Salmonella Contamination

    Mountain Mel's Essential Goods LLC is recalling The Milk Lady's Herbal Tea due to potential Salmonella contamination. The product was distributed in California, Oregon, and Washington.

    Product
    The Milk Lady's Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05658 4. The label is read in parts: "***The Milk Lady s FOR GREATER MILK FLOW & CALM NERVES***CAFFEINE-FREE HERBAL TEA*** Mountain Mel s Essential Goods, LLC Welches
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2479-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure

    OMNIlife science Inc. is recalling 14 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2019·2019-09-11

    B. Braun Epidural Tray Recall Due to Filter Membrane Damage

    B. Braun Medical is recalling 960 epidural trays because filter membrane damage prevents the filter from achieving its intended capacity.

    Product
    CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2355-2019·2019-09-11

    Norm-O-Temp 111Z Medical Device Recalled for Missing Tissue Damage Warning

    Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111Z devices because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.

    Product
    Norm-O-Temp model 111Z
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2435-2019·2019-09-11

    Integra Jarit GEMINI CLAMP Recalled Due to Potential Instrument Breakage

    Integra LifeSciences Corp. is recalling 237 units of the Jarit GEMINI CLAMP because a small crack may cause corrosion and breakage after repeated sterilization.

    Product
    Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2106-2019·2019-09-11

    Vitony Bakery Guava-Coconut Pudding Cake Recalled for Undeclared Sulfite

    Vitony Bakery is recalling 1,041 units of Guava-Coconut Pudding Cake because the product fails to declare sodium metabisulfite on the label.

    Product
    Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2480-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure

    OMNIlife science Inc. is recalling 22 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2019·2019-09-11

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling syngo.CT software version VA48A_SP5.5 for specific SOMATOM CT models due to scanning workflow interruptions and unexpected user notifications.

    Product
    syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2019·2019-09-11

    Haag-Streit Operating Microscope Floor Stand Software Error Recall

    Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS H
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2469-2019·2019-09-11

    B. Braun Medical Recalls Epidural Tuohy Needle Filters Due to Membrane Damage

    B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.

    Product
    CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
    Category
    Medical Device
    Distribution
    10 states

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