The Recall Desk

Archive

January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical
40
Severe
215
High
178
Moderate
85
Low
16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 40% are Severe.

201–300 of 534

  • SevereFDA (Drugs)·D-0736-2020·2020-01-22

    Assurance Infusion Recalls HCG Injections Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of HCG 3000U/1ML injections because they lack sterility assurance. The recall covers products distributed nationwide.

    Product
    HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0697-2020·2020-01-22

    Assurance Infusion Recalls BUP 2MG/HYDROM 2MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 2MG/HYDROM 2MG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.

    Product
    BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0760-2020·2020-01-22

    Assurance Infusion Recalls Morphine Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Morphine 6mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of multi-drug injection syringes because of a lack of sterility assurance.

    Product
    BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0673-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.

    Product
    BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0752-2020·2020-01-22

    Assurance Infusion Recalls Morphine Injection Due to Sterility Concerns

    Assurance Infusion is recalling Morphine 15mg/mL injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.

    Product
    MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX FORTE Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX FORTE in 1 mL vials because of a lack of sterility assurance. The recall covers 5 vials distributed nationwide.

    Product
    QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX in 1 mL vials because of a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0733-2020·2020-01-22

    Assurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns

    Assurance Infusion is recalling Fentanyl 800mcg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0688-2020·2020-01-22

    Assurance Infusion Recalls BUP 1MG//ML/HYDROM 7MG Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.

    Product
    BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0705-2020·2020-01-22

    Assurance Infusion Recalls BUP 3MG/HYDROM 15MG/ML INJ Syringes

    Assurance Infusion is recalling BUP 3MG/HYDROM 15MG/ML INJ syringes due to a lack of sterility assurance. The recall covers nationwide distribution.

    Product
    BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2020·2020-01-22

    Assurance Infusion Recalls Trimix Forte Plus Injection Vials for Sterility Concerns

    Assurance Infusion is recalling 20 vials of Trimix Forte Plus injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0744-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Hydromorphone 3mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0695-2020·2020-01-22

    Assurance Infusion Recalls BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0711-2020·2020-01-22

    Assurance Infusion Recalls BUP/FENT Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 5.3MG/FENT 1050 MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.

    Product
    BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0691-2020·2020-01-22

    Assurance Infusion Recalls BUP/CLON/FENT Injection Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of BUP 20MG/CLON 250MCG/FENT 7200MCG/ML Injection due to a lack of sterility assurance.

    Product
    BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0719-2020·2020-01-22

    Assurance Infusion Recalls BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ Syringes

    Assurance Infusion is recalling BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ syringes due to a lack of sterility assurance.

    Product
    BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0660-2020·2020-01-22

    Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

    Product
    Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0676-2020·2020-01-22

    Assurance Infusion Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Assurance Infusion is recalling specific lots of Baclofen injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0671-2020·2020-01-22

    Assurance Infusion Recalls BAC/FENT/MORP Injection Due to Sterility Concerns

    Assurance Infusion is recalling a specific lot of BAC/FENT/MORP injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0668-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0689-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0757-2020·2020-01-22

    Assurance Infusion Recalls Morphine Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Morphine 30mg/mL injection syringes due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0693-2020·2020-01-22

    Assurance Infusion Recalls BUP 20MG/SUF 1000MCG/ML Injection Syringes

    Assurance Infusion is recalling BUP 20MG/SUF 1000MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.

    Product
    BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

    Assurance Infusion is recalling Hydromorphone 15mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0702-2020·2020-01-22

    Assurance Infusion Recalls BUP 30MG/FENT 750MCG/HYDROM 15MG/ML Injection Syringes

    Assurance Infusion is recalling 20 mL syringes of BUP 30MG/FENT 750MCG/HYDROM 15MG/ML injection due to a lack of sterility assurance.

    Product
    BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2020·2020-01-22

    Assurance Infusion Recalls Sufentanil Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Sufentanil 150mcg/mL injection syringes due to a lack of sterility assurance.

    Product
    SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0706-2020·2020-01-22

    Assurance Infusion Recalls BUP 3 mg/MORP 15 mg/mL Injection Syringes

    Assurance Infusion is recalling BUP 3 mg/MORP 15 mg/mL Injection syringes due to a lack of sterility assurance. The recall covers specific lots distributed nationwide.

    Product
    BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0732-2020·2020-01-22

    Assurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns

    Assurance Infusion is recalling Fentanyl 5mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0700-2020·2020-01-22

    Assurance Infusion Recalls BUP 30MG/HYDROM 10MG/ML Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 30MG/HYDROM 10MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.

    Product
    BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0716-2020·2020-01-22

    Assurance Infusion Recalls BUP 675MCG/MORP 20MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 675MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance.

    Product
    BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2020·2020-01-22

    FDA Recalls Assurance Infusion Syringes Due to Sterility Assurance Issues

    Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 300MCG/FENT 1500MCG/ML injection due to a lack of sterility assurance.

    Product
    BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0703-2020·2020-01-22

    Assurance Infusion Recalls BUP 35MG/FENT 1.5MG/ML Syringes for Sterility Concerns

    Assurance Infusion is recalling BUP 35MG/FENT 1.5MG/ML in 20 mL syringes due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0817-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2020·2020-01-22

    Siemens ARTIS pheno X-Ray System Recalled for Potential Collision Sensor Blockage

    Siemens is recalling six ARTIS pheno X-ray systems because a collision sensor may falsely activate, permanently blocking system movement.

    Product
    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0549-2020·2020-01-22

    Wegmans Lobster Stuffed Portabella Recalled for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Portabella mushrooms because they contain undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Lobster Stuffed Portabella; Wegmans Ready to Cook Lobster Portabella Mushroom, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0542-2020·2020-01-22

    Wegmans Recalls Salmon with Crab Stuffing Due to Undeclared Soy

    Wegmans is recalling Salmon with Crab Stuffing because the product contains undeclared soy. Consumers should not eat the product and should return it to the store.

    Product
    Salmon with Crab Stuffing; Wegmans Salmon Topped with Crab Stuffing; 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0810-2020·2020-01-22

    Suntech Medical Recalls Model 250D Ambulatory Blood Pressure Monitors for Battery Safety

    Suntech Medical is recalling 384 Model 250D Ambulatory Blood Pressure Monitors due to a user safety issue involving the misuse of rechargeable batteries.

    Product
    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0531-2020·2020-01-22

    Wegmans Recalls Signature Crab Cakes Due to Undeclared Soy

    Wegmans is recalling Signature Crab Cakes in several states because they contain undeclared soy. Consumers should not eat the product and should return it to the store.

    Product
    Signature Crab Cake, Signature Crab Cake (2 pk), and Signature Crab Cake (4pk); Wegmans Ready to Cook Signature Crab Cake; Oven ready tray; various sizes, keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0541-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Tilapia for Undeclared Soy

    Wegmans is recalling Crab Stuffed Tilapia because the product contains undeclared soy. The recall affects stores in seven states.

    Product
    Crab Stuffed Tilapia; Wegmans ready to Cook Tilapia Stuffed with Crab; 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0533-2020·2020-01-22

    Wegmans Recalls Cajun Tilapia Cake Due to Undeclared Soy

    Wegmans is recalling Cajun Tilapia Cake because it contains undeclared soy. The product was sold in New York, Pennsylvania, Maryland, Virginia, New Jersey, Massachusetts, and North Carolina.

    Product
    Cajun Tilapia Cake; Tilapia cake sold by the 1lb; 1 each; Oven ready tray; various package sizes; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0536-2020·2020-01-22

    Wegmans Recalls Ready-to-Cook Crab Stuffing for Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffing sold in seven states because the product contains undeclared soy.

    Product
    Crab Stuffing; Wegmans Ready to Cook Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; package size varies, Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0806-2020·2020-01-22

    Carestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement

    Carestream Health is recalling 79 Kodak DirectView DR3000/3500 diagnostic x-ray systems due to a potential safety issue involving unintended movement of the U-Arm.

    Product
    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky ass
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0543-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Portobella for Undeclared Soy

    Wegmans is recalling Crab Stuffed Portobella mushrooms due to undeclared soy. The product was sold in seven states.

    Product
    Crab Stuffed Portobella; Wegmans Ready to Cook Portobella Mushroom with Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0501-2020·2020-01-22

    Buddy Brew Coffee Recalls Organic Cold Brew Coffee Due to Bacteria Risk

    Buddy Brew Coffee is recalling Organic Cold Brew Coffee Bolt Original cans and kegs due to potential bacterial contamination. The product was distributed in Florida.

    Product
    Organic Cold brew BUDDY BREW COFFEE BOLT Original 10.5 oz. cans and 5 and 7.5 gallon kegs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0504-2020·2020-01-22

    Hannaford Grilled Salmon Meal Recalled for Undeclared Wheat

    Taylor Farms is recalling Hannaford brand Grilled Salmon meals because they may contain undeclared wheat. Consumers with this product should not eat it.

    Product
    Hannaford brand Grilled Salmon meal with cooked brown rice, quinoa blend, broccoli florets, cooked white rice, fire roasted edamame, garlic and herb butter, bell pepper, roasted corn and carrots, Net Wt. 12.8 OZ (363g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0548-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Haddock Due to Undeclared Soy

    Wegmans is recalling Lobster Stuffed Haddock because the product contains undeclared soy. Consumers in seven states should check their refrigerators or freezers.

    Product
    Lobster Stuffed Haddock; Wegmans Ready to Cook Lobster Stuffed Haddock, 8 oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0550-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Mushrooms for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Mushrooms because they contain undeclared soy. The product was sold in seven states.

    Product
    Lobster Stuffed Mushrooms; Wegmans Ready to Cook Lobster Stuffed Mushrooms, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0546-2020·2020-01-22

    Wegmans Lobster Stuffed Pretzels Recalled for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Pretzels because they contain undeclared soy. The product was sold in seven states.

    Product
    Lobster Stuffed Pretzel; Wegmans Ready to Cook Lobster Pretzel Twist, 1 each; 15 oz; Oven Ready Tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0526-2020·2020-01-22

    Royal Farms Barbecue Dipping Sauce Recalled for Undeclared Soy Allergen

    Sauer Brands is recalling Royal Farms Barbecue Dipping Sauce because the label fails to declare the presence of soy lecithin, a major allergen.

    Product
    Royal Farms Barbecue Dipping Sauce, Net Wt. 1.5 OZ Distributed by Royal Farms, Baltimore MD packaged in plastic cups, 228 cups to a case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0547-2020·2020-01-22

    Wegmans Lobster Stuffed Salmon Recalled for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Salmon products because they contain undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Lobster Stuffed Salmon; Wegmans Ready to Cook Salmon Topped with Loster, 7 oz; oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0801-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and enter the patient's mouth.

    Product
    BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0545-2020·2020-01-22

    Wegmans Recalls Seafood Lobster Dip for Undeclared Soy

    Wegmans is recalling Seafood Lobster Dip sold in multiple states because the product contains undeclared soy.

    Product
    Seafood Lobster Dip; Wegmans Lobster Dip, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0534-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Salmon for Undeclared Soy Allergen

    Wegmans is recalling Crab Stuffed Salmon products because they contain undeclared soy. Consumers with soy allergies should not eat these items.

    Product
    Crab Stuffed Salmon; Crab Stuffed Salmon with Lemon Tarragon sauce; 1 each; Oven ready tray; Varied sizes; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0539-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Hatch Chile Peppers Due to Undeclared Soy

    Wegmans is recalling Crab Stuffed Hatch Chile Peppers because they contain undeclared soy. Consumers should not eat the product.

    Product
    Crab Stuffed Hatch Chile; Wegmans Ready to Cook Hatch Chile Peppers with Crab Stuffing, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0560-2020·2020-01-22

    Tobago Keys Seafood and Grilling Sauces Recalled for Undeclared Fish Allergen

    Endorphin Farms, Inc. is recalling Tobago Keys brand sauces due to mislabeling that resulted in an undeclared fish allergen.

    Product
    Tobago Keys brand Coral Ridge Seafood Dipping Sauce 12 FL.OZ. (355 ml) and Peruvian Gold Grilling Sauce 12 FL.OZ (355 ml)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0537-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Hot Peppers Due to Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffed Hot Peppers because they contain undeclared soy. The product was sold in seven states.

    Product
    Crab Stuffed Hot Peppers; Wegmans Ready to Cook Crab Stuffed Hot Peppers, Sold by the lb; Unit size varies; Oven ready tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0815-2020·2020-01-22

    Cook Inc. Recalls Dawson-Mueller Drainage Catheters Due to Leakage Risk

    Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters because they were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

    Product
    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2020·2020-01-22

    Stryker Omnifit Crossfire Hip Insert Recall Due to Missing Locking Wire

    Howmedica Osteonics Corp. is recalling 20 units of Stryker Omnifit Crossfire 10 Degree Series II Inserts due to a potential missing locking wire.

    Product
    Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Drugs)·D-0758-2020·2020-01-22

    Recall of Assurance Infusion Morphine Injection for Sterility Concerns

    Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes due to lack of sterility assurance. The recall affects specific lots distributed nationwide.

    Product
    MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0544-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Sea Bass for Undeclared Soy

    Wegmans is recalling Crab Stuffed Sea Bass because the product contains undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Crab Stuffed Sea Bass; Wegmans Ready to Cook Sea Bass with Crab Stuffing, 6 oz; Oven Ready Tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0500-2020·2020-01-22

    Sanity Chocolate Recalls Dark with Browned Ghee for Undeclared Milk

    Sanity Chocolate is recalling approximately 60 bars of Dark with Browned Ghee chocolate because the label declares ghee but fails to declare milk.

    Product
    Dark with Browned Ghee is wrapped in a foil and jacketed with black paper. There is a white sticker on the front that says Sanity Chocolate. On the back label there is the batch name listed above, address listed above and ingredient list. Average net weight is 0.75 oz. There i
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0816-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and separate, posing a risk of entering the patient's oral cavity.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2020·2020-01-22

    St. Jude Medical Recalls Confirm Rx Insertable Cardiac Monitors

    St. Jude Medical is recalling 2,906 Confirm Rx Insertable Cardiac Monitors because a software defect caused inappropriate low battery indicators.

    Product
    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2020·2020-01-22

    CooperSurgical Recalls Advanced Endosee Cannulas Due to Unsealed Pouches

    CooperSurgical is recalling 460 boxes of Advanced Endosee Cannulas because some sterile pouches may be unsealed, potentially compromising sterility.

    Product
    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Food)·F-0503-2020·2020-01-22

    Stop and Shop Grilled Salmon Meal Recalled for Undeclared Wheat

    Taylor Farms is recalling Stop and Shop Grilled Salmon meals due to undeclared wheat. Consumers with this product should not eat it.

    Product
    Stop and Shop brand Grilled Salmon meal with cooked brown rice, quinoa blend, broccoli florets, cooked white rice, fire roasted edamame, garlic and herb butter, bell pepper, roasted corn and carrots, Net Wt. 12.8 OZ (363g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0497-2020·2020-01-22

    Bakkavor Recalls Home Chef Baked Macaroni and Cheese Due to Plastic Contamination

    Bakkavor Foods USA Inc. is recalling 3,642 trays of Home Chef Baked Macaroni and Cheese because a customer reported finding pieces of black plastic in the product.

    Product
    HOME CHEF HEAT & EAT Baked Macaroni & Cheese NET WT. 12 oz (340G) keep refrigerated, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, UPC 8 12071 03555 9
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0532-2020·2020-01-22

    Wegmans Signature Crab Cake Recalled for Undeclared Soy

    Wegmans is recalling Signature Crab Cakes because they contain undeclared soy. The products were sold in seven states.

    Product
    Signature Crab Cake; Crab Cake with 2 oz Remoulade Sauce; 1 each; Oven ready tray; various package sizes; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0802-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0535-2020·2020-01-22

    Wegmans Crab Dip Recalled for Undeclared Soy Allergen

    Wegmans Food Markets is recalling Crab Dip with Jalapeno Cheddar Cheese because it contains undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Wegmans Crab Dip with Jalapeno Cheddar Cheese; Sold by the lb; Crab Dip with Jalapeno Cheddar Cheese; Size varies; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0538-2020·2020-01-22

    Wegmans Recalls Crab Pretzel Twists Due to Undeclared Soy

    Wegmans is recalling Ready to Pretzel Twist with Crab Stuffing because the product contains undeclared soy. Consumers with this product should not eat it.

    Product
    Crab Pretzel Twist; Wegmans Ready to Pretzel Twist with Crab Stuffing, 1 each; 14oz; Oven ready tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0540-2020·2020-01-22

    Wegmans Recalls Crab Stuffed Flounder Due to Undeclared Soy

    Wegmans is recalling Ready to Cook Crab Stuffed Flounder because the product contains undeclared soy. Consumers should not eat the product.

    Product
    Crab Stuffed Flounder; Wegmans Ready to Cook Crab Stuffed Flounder; 7oz; Oven Ready Tray; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0552-2020·2020-01-22

    Wegmans Recalls Lobster Stuffed Tilapia for Undeclared Soy

    Wegmans is recalling Lobster Stuffed Tilapia because the product contains undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Lobster Stuffed Tilapia; Wegmans Ready to Cook Lobster Stuffed Tilapia, 7 oz; Unit size 7oz; Oven Ready Tray; Package size 7oz; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0551-2020·2020-01-22

    Wegmans Recalls Crabmeat Stuffed Mushrooms for Undeclared Soy

    Wegmans is recalling Ready to Cook Crabmeat Stuffed Mushrooms sold in seven states because they contain undeclared soy.

    Product
    Crabmeat Stuffed Mushrooms; Wegmans Ready to Cook Crabmeat Stuffed Mushrooms, Sold by the lb; Unit size varies; Oven Ready Tray; Package size varies; Keep Refrigerated or Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0502-2020·2020-01-22

    Buddy Brew Coffee Recalls Organic Cold Brew Nitro Cans and Kegs

    Buddy Brew Coffee is recalling specific lots of Organic Cold Brew Nitro coffee due to potential bacterial contamination. The products were distributed in Florida.

    Product
    Organic Cold brew BUDDY BREW COFFEE BOLT NITRO 10.5 oz. cans and 5 and 7.5 gallon kegs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0773-2020·2020-01-22

    Assurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns

    Assurance Infusion is recalling 1,290 vials of TRIMIX injection nationwide due to a lack of sterility assurance. No specific illnesses or injuries are reported in the source text.

    Product
    TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2020·2020-01-22

    Sun Pharmaceutical Recalls Sumatriptan Succinate Tablets Due to Impurities

    Sun Pharmaceutical Industries is recalling specific lots of Sumatriptan Succinate 50 mg tablets because they failed impurity specifications.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0802-2020·2020-01-22

    McGuff Compounding Pharmacy Recalls Lipoic Acid Injection Due to Particulate Matter

    McGuff Compounding Pharmacy Services is recalling Lipoic Acid Injection vials because filmy or cloudy particulate matter was observed in the product.

    Product
    Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2020·2020-01-22

    Riverpoint Medical Recalls 18G Brachy Grids Due to Packaging Integrity

    Riverpoint Medical is recalling 3,234 sterile 18G Brachy Grids because the integrity of the sterile packaging is potentially compromised.

    Product
    Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0781-2020·2020-01-22

    Wisconsin Pharmacal Recalls Yeast Arrest Vaginal Suppositories Due to cGMP Violations

    Wisconsin Pharmacal Company is voluntarily recalling 44,373 cartons of Yeast Arrest vaginal suppositories due to current Good Manufacturing Practice (cGMP) violations.

    Product
    Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0780-2020·2020-01-22

    Letco Medical Recalls Subpotent Estriol USP Micronized Drug Products

    Letco Medical LLC is voluntarily recalling subpotent Estriol USP Micronized products distributed in the US and internationally.

    Product
    Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0521-2020·2020-01-22

    Bob's Red Mill 13 Bean Soup Mix Recalled for Glyphosate

    Bob's Red Mill is recalling 13 Bean Soup Mix due to the potential presence of glyphosate. The product was distributed in multiple US states and international locations.

    Product
    13 Bean Soup Mix is sold under Bob's Red Mill brand, packaged in Form & Fill (29 oz. and 822 gram), Standup Pouch (29 oz.), and Bulk Bags (25 lbs.) Product has the following UPC: UPC: 039978122513 UPC: 039978002518 UPC: 039978102515 (25 lb. bag) UPC: 039978302519 (distribu
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-0519-2020·2020-01-22

    Columbia Bean & Produce Recalls Dry Garbanzo Beans for Glyphosate

    Columbia Bean & Produce is recalling dry garbanzo beans sold under multiple brands because 11.8 ppm of glyphosate was detected.

    Product
    Dry Garbanzo Beans are sold under different brands and described as follows: -Bulk 2000 lbs. Totes. -CBP brand 25# Paper Bags 035084321925. -FIESTA brand 25# Paper Bags 035084225070. -Home Pride brand 50# Paper Bags 035084225070. -WinCo 24/1 lbs Small Pack 07055
    Category
    Food
    Distribution
    7 states

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