The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
64
Severe
328
High
307
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 41% are Severe.

1–100 of 807

  • CriticalNHTSA·19V782000·2019-10-31

    Mazda Recalls CX-7, CX-9, and Mazda6 for Air Bag Inflator Defect

    Mazda is recalling specific 2007-2012 CX-7, CX-9, and 2009-2012 Mazda6 vehicles because the front passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA CX-7, CX-9, MAZDA6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V783000·2019-10-31

    Gulf Stream Recalls 2020 Trailers Due to Gas Refrigerator Seal Defect

    Gulf Stream is recalling 2020 Amerilite, Conquest, Innsbruck, Grand River, Kingsport, and Trail Master trailers because the gas refrigerator may not be properly sealed, potentially releasing carbon monoxide or flammable LP gases.

    Product
    GULF STREAM — GULF STREAM TRAILMASTER, AMERILITE, INNSBRUCK, KINGSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V784000·2019-10-31

    Honda Recalls Pilot and Passport for Incomplete Body Welding

    Honda is recalling 2019-2020 Pilot and 2019 Passport vehicles because front frame members may not be fully welded, potentially reducing crash protection.

    Product
    HONDA — HONDA PILOT, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V781000·2019-10-31

    Mazda Recalls Vehicles Due to Front Passenger Air Bag Inflator Defect

    Mazda is recalling specific 2003-2008 models because front passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA MAZDA6, MPV, RX-8, MAZDASPEED6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20706·2019-10-31

    John Deere Recalls Compact Utility Tractors Due to Cab Bolt Failure Hazard

    John Deere is recalling 4044R, 4052R, and 4066R compact utility tractors because improperly torqued front cab support bolts can fail during a rollover, posing a crushing injury hazard.

    Product
    John Deere 4044R, 4052R and 4066R compact utility tractors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0063-2020·2019-10-30

    Mrs. Stratton's Salads Recalls Tuna Salad for Listeria Risk

    Mrs. Stratton's Salads is recalling 27,787 containers of tuna salad under four brand names due to potential Listeria monocytogenes contamination.

    Product
    Tuna salad under the following brand names: BALLARDS FARM Barboursville, WV 25504 UPC 076010000293 12 oz. plastic container, LAURA LYNN UPC 086854035368 12 oz. plastic container, MRS. STRATTON S SALADS Birmingham, AL 35219 UPC 075217100294 12 oz. plastic container, STAR FOOD PROD
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-0055-2020·2019-10-30

    Ample Hills Peppermint Pattie Ice Cream Recalled for Undeclared Peanut

    Ample Hills Manufacturing is recalling Peppermint Pattie ice cream because it may contain undeclared peanut allergen.

    Product
    Ample Hills Peppermint Pattie ice cream packed in 3 gallon tubs and half pint (8oz) cartons . Allergens: Contains: eggs, milk, soy
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0057-2020·2019-10-30

    Roland Black Caviar Recalled for Potential Botulism Contamination

    Roland Foods is recalling specific jars of Black Caviar due to potential Clostridium botulinum contamination. Consumers should check their pantries for the listed UPCs and batch codes.

    Product
    Roland Brand Black Caviar - Whole Grain Lumpfish (Lumpfish Roe) packed in glass jars - 2oz & 2x2oz, UPC: 41224200029; 3.5oz, UPC: 41224200203; 12oz, UPCs: 41224200401 & 41224200425
    Category
    Food
    Distribution
    27 states
  • CriticalFDA (Food)·F-0089-2020·2019-10-30

    Lipari Foods Recalls Chicken Sandwiches for Listeria Risk

    Lipari Foods is recalling Premo Signature Cranberry Almond Chicken Salad croissant sandwiches because the chicken may be contaminated with Listeria monocytogenes.

    Product
    Premo Signature Cranberry Almond Chicken Salad croissant sandwich, 5 oz., with UPC code 612510090954
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0086-2020·2019-10-30

    Samurai Brand Furikake Popcorn Recalled for Undeclared Fish Allergen

    Samurai, Inc. is recalling Samurai Brand Furikake Popcorn because it contains an undeclared fish allergen. The product was distributed in Hawaii.

    Product
    Samurai Brand Furikake Popcorn Net Wt. 5 oz. (142g), foil bag - sold by single bag or case of 20 Made in Hawaii BAG UPC: 6 16720 40004 6; Case UPC: 6 16720 41004 5.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0056-2020·2019-10-30

    SuperMom's Chicken Salad Sandwiches Recalled for Listeria Risk

    Northern Tier Bakery LLC is recalling chicken salad sandwiches due to potential Listeria monocytogenes contamination. Products were distributed in Minnesota and Wisconsin.

    Product
    Chicken Salad Sandwiches packaged under the following brands: 1. Supermom's Kitchen Classic, Keep Refrigerated, UPC 7 63913-80128 6, Net Wt. 4.5 oz. (128g), MFG By Supermom's, St. Paul Park, MN 55071 2. Hometown Kitchen Select, Keep Refrigerated, UPC 7 63913-26015, Net W
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0096-2020·2019-10-30

    Coborn's Recalls Chicken Salad Sandwiches Due to Listeria Risk

    Coborn's, Inc. is recalling Chicken Salad Sandwiches because they may be contaminated with Listeria monocytogenes. The products were distributed in Minnesota, North Dakota, South Dakota, and Wisconsin.

    Product
    Chicken Salad Sandwich, UPC 2 07209-XXXXX. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0088-2020·2019-10-30

    Lipari Foods Recalls Chicken Salad Wheat Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo and Fresh Grab Chicken Salad wheat sandwiches because the chicken may be contaminated with Listeria monocytogenes.

    Product
    Premo and Fresh Grab Chicken Salad wheat sandwiches, 5 oz., with UPC code 612510002032.
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0058-2020·2019-10-30

    Roland Brand Red Caviar Recalled for Potential Botulism Contamination

    Roland Foods is recalling specific jars of Red Caviar due to potential Clostridium botulinum contamination. Consumers should check their pantries for the listed UPCs and batch codes.

    Product
    Roland Brand Red Caviar - Whole Grain Lumpfish (Lumpfish Roe) packed in glass jars - 2oz & 2x2oz, UPC: 41224202023; 3.5oz, UPC: 41224202207; 12oz, UPCs: 41224202405 & 41224202420
    Category
    Food
    Distribution
    27 states
  • CriticalFDA (Food)·F-0090-2020·2019-10-30

    Lipari Foods Recalls Ham and Cheese Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo and Fresh Grab Ham & Cheese wheat sandwiches because they contain chicken recalled for potential Listeria monocytogenes contamination.

    Product
    Premo and Fresh Grab Ham & Cheese wheat sandwich, 5 oz., with UPC code 612510002001
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0129-2020·2019-10-30

    Whole Foods Recalls Consider Bardwell Farm Dorset Cheese for Listeria Risk

    Whole Foods Market is recalling sliced Consider Bardwell Farm Dorset cheese due to a potential Listeria monocytogenes contamination.

    Product
    Consider Bardwell Farm Dorset cheese PLU code 97776 sliced and wrapped in plastic cling with Whole Foods Market scale label applied
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0149-2020·2019-10-30

    Nephron Recalls Fentanyl and Ropivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 615 bags of Fentanyl and Ropivacaine Injection due to potential glass contamination from GMP deviations.

    Product
    PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0068-2020·2019-10-30

    Veritable Vegetable Recalls Jayleaf Fresh Baby Spinach Due to E. coli Risk

    Veritable Vegetable is recalling Jayleaf Fresh Baby Spinach after customer reports of presumptive positive results for Shiga Toxin-Producing E. coli.

    Product
    Jayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0152-2020·2019-10-30

    Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0094-2020·2019-10-30

    Coborn's Recalls Chicken Salad Sandwiches for Listeria Risk

    Coborn's, Inc. is recalling Chicken Salad on Marble Rye sandwiches due to the potential for Listeria monocytogenes contamination.

    Product
    Chicken Salad on Marble Rye, UPC 2 05118-XXXXX. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0151-2020·2019-10-30

    Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.

    Product
    del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0095-2020·2019-10-30

    Coborn's Recalls Chicken Salad Croissant Sandwiches Due to Listeria Risk

    Coborn's is recalling Chicken Salad Croissant Sandwiches because they may be contaminated with Listeria monocytogenes. The products were distributed in Minnesota, North Dakota, South Dakota, and Wisconsin.

    Product
    Chicken Salad Croissant Sandwich, UPC 2 07275-XXXXX. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0150-2020·2019-10-30

    Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns

    Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software for Incorrect Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0072-2020·2019-10-30

    Euphoria Fancy Food Recalls Capitan K Salmon Due to Listeria Risk

    Euphoria Fancy Food Inc. is recalling Capitan K Salmon slightly salted pieces due to potential Listeria monocytogenes contamination. The product was distributed in New York, Pennsylvania, New Jersey, and Washington.

    Product
    Capitan K Salmon slightly salted piece - net.wt 1.05 oz (200g) Distributed by: Euphoria Fancy Food Inc. 149-151 2nd avenue Brooklyn, New York 11215, USA Product of Russia UPC: 607059000362
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0147-2020·2019-10-30

    Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.

    Product
    PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2020·2019-10-30

    Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk

    Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.

    Product
    Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0148-2020·2019-10-30

    Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 1,370 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.

    Product
    PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0187-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0170-2020·2019-10-30

    GN Otometrics Recalls ICS CHARTR EP 200 Due to Electrical Shock Risk

    GN Otometrics is recalling 3,071 ICS CHARTR EP 200 units because undergrounded electrical surfaces may cause electrical shock to patients or healthcare professionals.

    Product
    The ICS CHARTR EP 200
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0174-2020·2019-10-30

    Medline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk

    Medline Industries is recalling Semi-Rigid Suction Canisters because the lids may fragment during use, posing a risk to patients and healthcare workers.

    Product
    Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V778000·2019-10-30

    Temp-Air Recalls 2017-2019 EBB-80 Trailers Due to Hitch Coupling Defect

    Temp-Air is recalling 2017-2019 EBB-80 trailers because an incorrect hitch coupling may limit adjustability, potentially causing the trailer to drag and increasing crash risk.

    Product
    TEMP AIR — TEMP AIR EBB-80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2020·2019-10-30

    BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation

    Becton Dickinson is recalling 1.7 million BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the needle retracts.

    Product
    BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2020·2019-10-30

    Rifton TRAM Standard Base Recalled for Latch Mechanism Fatigue Failure Risk

    Community Products, LLC is recalling 3,282 Rifton TRAM Standard Base powered lift devices due to a design defect that may cause the latch mechanism to fail after repeated use.

    Product
    Rifton TRAM Standard Base, SKU K310, powered lift device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0074-2020·2019-10-30

    Koppers Chocolate Gummy Bears Recalled for Missing Milk Allergen Labeling

    The Newark Nut Store is recalling Koppers Chocolate Dark Chocolate Gummy Bears because the packaging fails to list milk as an allergen.

    Product
    Koppers Chocolate Dark Chocolate Gummy Bears, 4oz (113g) retail package, metallized foil resealable pouch, 12 pouches per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0183-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings

    Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2020·2019-10-30

    Rifton TRAM Low Base Lift Device Recalled for Buckle Fatigue Failure

    Community Products is recalling 1,079 Rifton TRAM Low Base powered lift devices because a design change makes the latch springs susceptible to fatigue failure.

    Product
    Rifton TRAM Low Base, SKU K320, powered lift device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2020·2019-10-30

    Beckman Coulter Lipase Recalled Due to Acetaminophen Interference

    Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.

    Product
    Beckman Coulter Lipase, REF OSR6130 and OSR6230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0062-2020·2019-10-30

    Dole Crushed Pineapple Recalled for Potential Plastic Pieces

    Dole Packaged Foods is recalling specific lots of crushed pineapple due to the potential presence of foreign plastic pieces.

    Product
    Dole Crushed Pineapple in 100% pineapple juice Manufactured For Dole Packaged Foods, LLC Westlake Village, CA 91361 Product of The Philippines UPC 3890000613
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0082-2020·2019-10-30

    Infinite Herbs Recalls Conventional Basil Potentially Contaminated with Cyclospora

    Infinite Herbs, LLC is recalling conventional basil potentially contaminated with Cyclospora. The product was distributed to one retail customer and three distributors.

    Product
    Conventional Basil with Basil Infinite Herbs & Specialties brand label. Basil was packed in 2.5 oz plastic clamshell, 4.0 oz. plastic clamshell, and 1 lb plastic bags.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0182-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 1,759 cases of sterile Co-Flex LF2 wound dressings because of incomplete packaging seals, which may compromise sterility.

    Product
    Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0073-2020·2019-10-30

    Trails End Sweet and Savory Collection Recalled for Undeclared Nuts

    Weaver Fundraising is recalling the Trails End Sweet and Savory Collection due to inaccurate nutrition facts and undeclared almonds, cashews, and pecans.

    Product
    Trails End Sweet and Savory Collection, containing White Cheddar cheese Corn (5 oz.), Butter Toffee Carmel Corn (20 oz.), and Chocolatey Caramel Crunch (15 oz.) each in individual foil bags packaged together in variety box
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0054-2020·2019-10-30

    Tia Rita's Cornbread Mix Recalled for Undeclared Wheat Allergen

    The Truck Farm, LLC is recalling Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix because the product contains wheat flour but does not declare wheat on the label.

    Product
    Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix. Packaged in 13 oz (380 g) sealed plastic bags with paper label stapled over the top edge of each package, 12 packages per case. UPC 44107 10062. Mfg. by The Truck Farm, LLC. Las Cruces, NM 88005.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2020·2019-10-30

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 47,152 Plum 360 Infusion Systems because a software malfunction can cause the device to become inoperable with a blank screen when used with a MedNet Custom Drug Library.

    Product
    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2020·2019-10-30

    IrriMAX Recalls Irrisept Wound Debridement System Due to Seal Defect

    IrriMAX Corporation is recalling 1,031 cases of Irrisept Wound Debridement and Cleansing Systems because a potential defect in the sterile pouch seal may result in a lack of sterility assurance.

    Product
    Irrisept Wound Debridement and Cleansing System. 12 units per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2020·2019-10-30

    Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk

    Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the des
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2020·2019-10-30

    Rifton E-Pacer Powered Lift Device Recalled for Buckle Fatigue Failure

    Community Products, LLC is recalling 167 Rifton E-Pacer powered lift devices because a design change makes the load-bearing buckle springs susceptible to fatigue failure.

    Product
    Rifton E-Pacer, SKU K660, powered lift device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

    Product
    Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0190-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles from the PORT-A-CATH II system because they may be occluded or blocked.

    Product
    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

    Product
    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

    Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2020·2019-10-30

    Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

    Product
    Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0161-2020·2019-10-30

    Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results

    Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.

    Product
    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0175-2020·2019-10-30

    GE Healthcare ApexPro Telemetry Server System Recall for Alarm Failure

    GE Healthcare is recalling ApexPro Telemetry Server Systems because they may fail to provide visual or audible alarms for ECG arrhythmias, lead failures, or pulse oximetry issues.

    Product
    ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2020·2019-10-30

    Candela Surgical Laser Coolant Canisters Recalled for Loose Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

    Product
    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0173-2020·2019-10-30

    Abbott Recalls Emerald Diluent Tubing Due to Cloudiness and Film

    Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers with diluent tubing that appears cloudy or has a film, which may cause falsely elevated platelet results.

    Product
    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0188-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0186-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0211-2020·2019-10-30

    Beckman Coulter Uric Acid Assay Recalled Due to Interference

    Beckman Coulter is recalling Uric Acid assays because acetaminophen metabolites cause negative interference in overdose patients.

    Product
    Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues

    Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2020·2019-10-30

    Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2020·2019-10-30

    OMNI Hip System Femoral Component Recalled for Missing Porous Coating

    OMNIlife science Inc. is recalling three OMNI Hip System femoral components because they are missing the required porous coating.

    Product
    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0059-2020·2019-10-30

    Shirakiku Buckwheat Noodles Recalled for Undeclared Fish Allergens

    Wismettac Asian Foods is recalling Shirakiku Buckwheat Noodles because the dipping sauce contains undeclared tuna and fails to list fish as an allergen.

    Product
    Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration Soup Base, 435G SK, UPC 074410455200 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0176-2020·2019-10-30

    Brainlab Patient Data Manager Software Recall for Data Export Errors

    Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.

    Product
    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled Due to Loose Neck Bushing

    Candela is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

    Product
    Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Food)·F-0069-2020·2019-10-30

    Kenzen Calcium Complex Recalled for Missing Milk Allergen Labeling

    HP Ingredients is recalling Kenzen Calcium Complex tablets because the label lacks the required 'Contains: milk' advisory.

    Product
    NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0071-2020·2019-10-30

    Sugar Mill Farms Focused Energy Recalled for Undeclared Yellow #6

    Hall Global, LLC is recalling Sugar Mill Farms Focused Energy hemp extract products because the label fails to declare Yellow #6 and lists incorrect ingredients and flavors.

    Product
    Sugar Mill Farms Focused Energy 25 mg Hemp Extract Berry Flavor 7.25 g 5 blast cap count
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0070-2020·2019-10-30

    Hall Global Recalls OXZGEN CBD Capsules for Labeling Errors

    Hall Global, LLC is recalling OXZGEN Performance CBD capsules because the label fails to declare Yellow #6 and lists an incorrect amount of Vitamin B2.

    Product
    OXZGEN Performance 25 mg Hemp Derived CBD + Teacrine + BCAA Orange Flavored, 5 blast caps, 2.2 FL OZ
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0160-2020·2019-10-30

    Siemens Mammomat Revelation Recall for Biopsy Software Error

    Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.

    Product
    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects

    Andover Healthcare Inc. is recalling 1,050 cases of Sterile Co-Flex Med 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0192-2020·2019-10-30

    Arrow AGB+ Multi-Lumen CVC Kit Recalled for Incorrect Lidstock Labeling

    Arrow International Inc is recalling 745 units of the AGB+ Multi-Lumen CVC Kit because the lidstock label incorrectly lists the product code and catheter length.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0061-2020·2019-10-30

    Source Naturals Brain Charge Recalled for Labeling Errors

    Threshold Enterprises Ltd is recalling Source Naturals Brain Charge dietary supplements because the label claims for two ingredients were lower than the actual product formulation.

    Product
    Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143
    Category
    Food
    Distribution
    30 states
  • LowFDA (Devices)·Z-0162-2020·2019-10-30

    Xintec OptiLITE Laser Fiber Assembly Recall Due to Programming Error

    Xintec Corp is recalling 45 OptiLITE laser fiber assemblies because they were programmed incorrectly. The devices will produce an error and prevent laser use.

    Product
    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
    Category
    Medical Device
    Distribution
    2 states
  • SevereUSDA FSIS·105-2019·2019-10-29

    H&T Seafood Recalls Frozen Swai Fillets Lacking USDA Inspection

    H&T Seafood Inc. is recalling frozen Swai fillets that were produced and distributed without USDA inspection. No adverse reactions have been reported.

    Product
    H&T Seafood Inc. Recalls Siluriformes Products Produced Without the Benefit of Inspection
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·19V776000·2019-10-29

    Indian Recalls 2014-2019 Motorcycles Due to Gear Position Switch Defect

    Indian Motorcycle is recalling 2014-2019 Chief, Chieftain, Roadmaster, and Springfield models because the gear position switch may oxidize, causing the display to incorrectly show neutral when the bike is in gear.

    Product
    INDIAN — INDIAN CHIEFTAIN, SPRINGFIELD, ROADMASTER, CHIEF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V777000·2019-10-29

    Prevost Recalls 2020 Coaches Due to Dash Brightness Control Defect

    Prevost is recalling 110 specific 2020 coaches because a missing component prevents drivers from adjusting dash brightness, potentially reducing visibility at night.

    Product
    PREVOST — PREVOST H3-45, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V770000·2019-10-28

    Mazda Recalls 2019 CX-9 Vehicles Due to Tire Tread Separation Risk

    Mazda is recalling 2019 CX-9 vehicles equipped with specific Sumitomo Falken tires because an incorrect rubber compound may cause the tread to separate, increasing crash risk.

    Product
    MAZDA — MAZDA CX-9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·104-2019·2019-10-28

    OSI Recalls Frozen Beef Patties Due to Possible Metal Contamination

    OSI Industries is recalling approximately 4,218 pounds of frozen, ready-to-eat beef patties that may contain metal. No adverse reactions have been reported.

    Product
    OSI Industries, LLC — OSI Industries, LLC Recalls Ready-To-Eat Beef Patty Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V773000·2019-10-28

    Ford Recalls 2019 Expedition and Lincoln Navigator for Rear Suspension Defect

    Ford is recalling 2019 Expedition and Lincoln Navigator vehicles because rear suspension fasteners may not be properly tightened, which could cause a sudden change in vehicle handling.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V775000·2019-10-28

    Thor Motor Coach Recalls 378 Motorhomes for Seatbelt Warning Defect

    Thor Motor Coach is recalling 378 motorhomes because the seatbelt-unfastened warning light may not illuminate for five seconds after starting, increasing crash injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR FOUR WINDS, DAYBREAK, CHATEAU, FREEDOM ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V768000·2019-10-25

    Mercedes-Benz Recalls 2019 SL Models for Rear Axle Bolt Failure

    Mercedes-Benz is recalling 2019 SL 450, SL 550, and AMG SL63 vehicles because a rear axle bolt may fail, affecting handling and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SL 450, SL 550, AMG SL63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V769000·2019-10-25

    Western Star 4700 Recalled for Steering Shaft Installation Defect

    Daimler Trucks North America is recalling 2020 Western Star 4700 vehicles because an improperly installed steering shaft could disconnect from the front axle, causing loss of steering control.

    Product
    WESTERN STAR — WESTERN STAR 4700
    Category
    Vehicle
    Distribution
    Distributed nationwide

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