The Recall Desk

Archive

March 2020 recalls

515 recalls were announced in March 2020.

What the numbers show

Critical
16
Severe
165
High
214
Moderate
96
Low
24

Of the 515 recalls this month scored against our rubric, 3% are Critical, 32% are Severe.

Which agencies issued them

301–400 of 515

  • SevereFDA (Drugs)·D-0943-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Betamethasone Acetate/Betamethasone Injectable Suspension due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0960-2020·2020-03-11

    Axia Pharmaceutical Recalls Polidocanol Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Polidocanol Injection because the company cannot guarantee the product is sterile.

    Product
    Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2020·2020-03-11

    Axia Pharmaceutical Recalls Glycerin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Glycerin (PF) Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in several international locations.

    Product
    Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0946-2020·2020-03-11

    Axia Pharmaceutical Recalls Calcium Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Calcium Chloride Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in several international locations.

    Product
    Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0987-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0936-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Alprostadil injectable because the sterility of the product cannot be assured. Patients should stop using the recalled medication and consult their healthcare provider.

    Product
    Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0982-2020·2020-03-11

    Axia Pharmaceutical Recalls Super MIC Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Super MIC Injection, a vitamin complex, due to a lack of assurance of sterility.

    Product
    Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0980-2020·2020-03-11

    Axia Pharmaceutical Recalls Pyridoxine Hydrochloride Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Pyridoxine Hydrochloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in several Caribbean territories.

    Product
    Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1362-2020·2020-03-11

    CareFusion Alaris PCA Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris PCA Module, Model 8120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0934-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility. The product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0935-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil injectable vials due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0945-2020·2020-03-11

    Axia Pharmaceutical Recalls Biotin Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Biotin Injectable Suspension due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1415-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0794-2020·2020-03-11

    Grain Processing Recalls Corn Starch Due to Metal Slivers

    Grain Processing Corporation is recalling 3,790 bags of Pure Dent B700 Food Corn Starch because a customer reported the presence of metal slivers.

    Product
    Pure Dent¿ B700 Food Corn Starch packaged in 50 lb bags
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0970-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0942-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Betamethasone Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. St
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0983-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate Injection because the company cannot guarantee the product is sterile.

    Product
    Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2020·2020-03-11

    Axia Pharmaceutical Recalls AscorbiX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0765-2020·2020-03-11

    Whole Foods Recalls Marble Bundt Cake Slices Due to Undeclared Milk

    Whole Foods Market is recalling 241 slices of Marble Bundt Cake sold in specific states because the product contains undeclared milk.

    Product
    Marble Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 45162
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0767-2020·2020-03-11

    Whole Foods Recalls Chocolate Dipped Coconut Macaroon Cookies for Undeclared Milk

    Whole Foods Market is recalling 109 chocolate dipped coconut macaroon cookies due to undeclared milk. The cookies were sold in seven states and Washington D.C.

    Product
    Chocolate Dipped Coconut Macaroon Cookie sold by the individual cookie packaged in Self Serve and Plastic clam shell containers PLU 48454
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0796-2020·2020-03-11

    Premiere Choice Peanut Butter Cookie Dough Recalled for Undeclared Milk

    Choice Products LLC is recalling 275 tubs of Premiere Choice Peanut Butter Cookie Dough because the product may contain undeclared milk.

    Product
    Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, Net Wt. 48 oz (1360g) UPC 6 98240 00412 6. Made by: Club's Choice Fundraising, Eau Claire, WI 54703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0969-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension

    Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0993-2020·2020-03-11

    Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection because the product may lack assurance of sterility.

    Product
    Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0965-2020·2020-03-11

    Axia Pharmaceutical Recalls Methionine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Methionine/Inositol/Choline Injection due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the company cannot assure the sterility of the product.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2020·2020-03-11

    Axia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0949-2020·2020-03-11

    Axia Pharmaceutical Recalls Cyanocobalamin/Folinic Acid Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Cyanocobalamin/Folinic Acid Injection because the product lacks assurance of sterility.

    Product
    Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0948-2020·2020-03-11

    Axia Pharmaceutical Recalls Cyanocobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Cyanocobalamin Injection because the product lacks assurance of sterility.

    Product
    Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2020·2020-03-11

    Axia Pharmaceutical Recalls AscorbiX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2020·2020-03-11

    Axia Pharmaceutical Recalls B-Complex 110 Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling B-Complex 110 Injectable vials due to a lack of assurance of sterility. The affected lots were distributed nationwide and in several international locations.

    Product
    B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0957-2020·2020-03-11

    Axia Pharmaceutical Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Hydroxocobalamin Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in several international locations.

    Product
    Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0339-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0947-2020·2020-03-11

    Axia Pharmaceutical Recalls Coenzyme Q10 Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling Coenzyme Q10 Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0787-2020·2020-03-11

    Aminature L-Cysteine HCl Recalled for Foreign Metal Material

    CJ Haide (Ningbo) Biotech Co., Ltd is recalling Aminature L-Cysteine HCl Anhydrous due to the presence of foreign metal material.

    Product
    Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0764-2020·2020-03-11

    Whole Foods Recalls Chocolate Fudge Mini Bundt Cake Slices for Undeclared Milk

    Whole Foods Market is recalling Chocolate Fudge Mini Bundt Cake slices sold in seven states and D.C. due to undeclared milk, a major allergen.

    Product
    Chocolate Fudge Mini Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 21287
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·20V140000·2020-03-11

    Heartland Recalls 2020 Shadow Cruiser Ultra Lite Trailers Due to Label Error

    Heartland is recalling 2020 Shadow Cruiser Ultra Lite trailers because certification labels list incorrect GVWR and axle ratings, which could lead to overloading and axle failure.

    Product
    CRUISER RV — CRUISER RV SHADOW CRUISER ULTRA LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2020·2020-03-11

    Seca Baby Scale Cart Recalled Due to Wheel Detachment Risk

    Seca is recalling 254 baby scale carts because wheels can loosen and detach, causing the cart to tip over and potentially injure a baby.

    Product
    Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1443-2020·2020-03-11

    RespVent Closed Suction System Tracheostomy T-Piece Recall for Connection Defect

    Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.

    Product
    RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1432-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.

    Product
    Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1439-2020·2020-03-11

    Vyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures

    Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.

    Product
    bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1447-2020·2020-03-11

    Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns

    Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.

    Product
    Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1413-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1411-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1410-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination

    DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0986-2020·2020-03-11

    Recall of Triamcinolone Acetonide/Bupivacaine Injectable Suspension Due to Sterility Concerns

    FDA recalls Triamcinolone Acetonide/Bupivacaine Injectable Suspension due to lack of sterility assurance. The drug was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0786-2020·2020-03-11

    Michele's Granola Recalls Salted Maple Pecan Granola Due to Labeling Error

    Michele's Granola LLC is recalling Salted Maple Pecan Granola because the ingredient list on the label fails to disclose pecans.

    Product
    Michele s Granola, MOM s Salted Maple Pecan Granola, 4 Cases of 12-12 oz. stand up pouches.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1359-2020·2020-03-11

    CareFusion Alaris PC Unit Software Error Recall

    CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, or incorrect medication concentrations.

    Product
    CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0766-2020·2020-03-11

    Whole Foods Recalls Dark Chocolate Dipped Almond Horn Cookies for Undeclared Milk

    Whole Foods Market is recalling Dark Chocolate Dipped Almond Horn Cookies due to undeclared milk. The recall affects 109 cookies sold in seven states and D.C.

    Product
    Dark Chocolate Dipped Almond Horn Cookie sold by the individual cookie packaged in Self Serve and Plastic clam shell containers PLU 33579
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1444-2020·2020-03-11

    Roche Recalls Elecsys CA 19-9 Reagent Due to Non-Reproducible Results

    Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.

    Product
    Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2020·2020-03-11

    CareFusion Alaris Pump Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Pump Module, Model 8100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2020·2020-03-11

    CareFusion Alaris Syringe Module Software Error Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Syringe Module, Model 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2020·2020-03-11

    Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1445-2020·2020-03-11

    Stryker Connected OR Cart Recalled Due to Monitor Attachment Defect

    Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.

    Product
    Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V141000·2020-03-11

    Turtle Top Odyssey Recall for Seatbelt Warning Light Defect

    Turtle Top is recalling 2019 Odyssey vehicles because the seatbelt-unfastened warning light may not illuminate for five seconds after ignition, increasing crash injury risk.

    Product
    TURTLE TOP — TURTLE TOP ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0984-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Testosterone Cypionate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0967-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylcobalamin Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2020·2020-03-11

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Foreign Matter

    Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.

    Product
    Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2020·2020-03-11

    Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding

    Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.

    Product
    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1423-2020·2020-03-11

    Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference

    Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1422-2020·2020-03-11

    Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference

    Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.

    Product
    Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1424-2020·2020-03-11

    Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1419-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1417-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1425-2020·2020-03-11

    Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk

    Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.

    Product
    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1431-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Sterility and Function Defects

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1421-2020·2020-03-11

    Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects

    Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.

    Product
    Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2020·2020-03-11

    Recall of Covidien Force TriVerse Electrosurgical Devices Due to Packaging Risk

    The FDA is recalling 70,361 units of Covidien Force TriVerse Electrosurgical Devices because sterile packaging may be compromised, increasing the risk of infection.

    Product
    Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2020·2020-03-11

    Polymer Technology Systems Recalls PTS Detect Cotinine In Vitro Diagnostic

    Polymer Technology Systems is recalling PTS Detect Cotinine in vitro diagnostic devices due to a lack of FDA 510(k) clearance.

    Product
    PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2020·2020-03-11

    Medtronic Recalls McGRATH X3 Disposable Laryngoscope Blades Due to Fit Issues

    Medtronic is recalling McGRATH X3 Disposable Laryngoscope Blades because they may not fit the video laryngoscope handle or fit too tightly, potentially affecting optical performance.

    Product
    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid lar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0773-2020·2020-03-11

    Mothers' Milk Bank of Louisiana Recalls Donor Human Milk Bottles

    Mothers' Milk Bank of Louisiana at Ochsner Baptist is recalling 60 bottles of donor human milk due to a foreign object found in a bottle.

    Product
    Donor human milk in 3 oz. plastic bottles.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0775-2020·2020-03-11

    Natural Grocers Organic Extra Virgin Coconut Oil Recalled for Mold

    Vitamin Cottage Natural Food Markets is recalling Natural Grocers Organic Extra Virgin Coconut Oil because product tested high for mold.

    Product
    Natural Grocers Organic Extra Virgin Coconut Oil, packaged in glass jars with metal lids and a plastic shrink seal, 17.5 oz. (518 mL), UPC# 849327-000368, Vitamin Cottage Natural Foods Markets (dba Natural Grocers) Lakewood, CO 80228. 12 units (jars)/case in cardboard box.
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1436-2020·2020-03-11

    Siemens Atellica IM Humidity Pack Software Error Recall

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs due to a software error that causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1435-2020·2020-03-11

    Siemens Atellica IM Humidity Pack Recall Due to Software Error

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs because a software error causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0774-2020·2020-03-11

    Driscoll's Raspberries Recalled for Pesticide Residue Exceeding Limits

    Driscoll's Inc. is recalling raspberries because in-house testing found Zeta-cypermethrin levels above the U.S. maximum residue limit.

    Product
    Driscoll's Raspberries- 6 oz. clamshell container 12 x 6 oz. per crate and 6 x 12 x 6 oz. (2 - 6 oz. attached clamshells) per crate UPC: 7 15756 10001 9 Product of Mexico
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0795-2020·2020-03-11

    Sticky Fingers Bakeries Gluten-Free Scones Recalled for Wheat Ingredient

    Custom Foods LLC is recalling Sticky Fingers Bakeries Gluten-Free Scones because wheat is listed in the ingredients, posing a risk to individuals with celiac disease or gluten sensitivity.

    Product
    Sticky Fingers Bakeries Gluten-Free Scones, Quick & Easy Mix, Meyer Lemon; Net Wt. 14 oz. (0.875 LBS) 396.9g. In Ingredient list: Lemon Flavored Pieces {sugar, enriched wheat flour (wheat flour, niacin, reduced iron Thiamin mononitrate, riboflavin, folic acid) Sticky Finger
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2020·2020-03-11

    Tosoh AIA-360 Analyzer Recalled Due to Display Screen Software Freeze

    Tosoh Bioscience Inc is recalling 12 AIA-360 Automated Immunoassay Analyzers because a software issue causes the display to freeze and stop the instrument.

    Product
    AIA-360 Automated Immunoassay Analyzer, Product Code 019945
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0776-2020·2020-03-11

    Natural Grocers Organic Extra Virgin Coconut Oil Recalled for Mold

    Vitamin Cottage Natural Food Markets is recalling 5,220 jars of Natural Grocers Organic Extra Virgin Coconut Oil because the product tested high for mold.

    Product
    Natural Grocers Organic Extra Virgin Coconut Oil, packaged in glass jars with metal lids and a plastic shrink seal, 32 oz. (946 mL), UPC# 849327-000375, Vitamin Cottage Natural Foods Markets (dba Natural Grocers) Lakewood, CO 80228. 12 units (jars)/case in cardboard box.
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0862-2020·2020-03-11

    Teva Recalls Mesalamine Tablets Due to Dissolution Test Failures

    Teva Pharmaceuticals USA is recalling 3,695 bottles of Mesalamine Delayed-Release Tablets because stability testing showed low dissolution results.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1434-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1433-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • LowFDA (Drugs)·D-0868-2020·2020-03-11

    AAA Pharmaceutical Recalls Fexofenadine Tablets for Labeling Errors

    AAA Pharmaceutical, Inc. is recalling specific lots of Discount Drug Mart Fexofenadine Hydrochloride Tablets due to incorrect or missing lot and expiration dates.

    Product
    Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distribute
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0964-2020·2020-03-11

    Axia Pharmaceutical Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection because the company cannot assure the product's sterility.

    Product
    Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2020·2020-03-11

    Advanced Bionics Recalls SoundWave Professional Suite Software 3.2

    Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.

    Product
    SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V137000·2020-03-09

    Ford Recalls 2019 Rangers for HVAC Blower Motor Fire Risk

    Ford is recalling 2019 Rangers previously repaired under recall 19V-726 because the replacement HVAC blower motor may have an electrical short that increases fire risk.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V135000·2020-03-06

    Volkswagen Recalls 2019 Arteon Vehicles for Brake Booster Defect

    Volkswagen is recalling 2019 Arteon vehicles because an incorrectly installed electronic brake booster rod may increase braking force or disconnect, raising crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ARTEON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V133000·2020-03-06

    Micro Bird Recalls School and Transit Buses for Emergency Door Defect

    Micro Bird is recalling 2004-2021 school and transit buses because the emergency door retaining device may fail to keep the door open, increasing injury risk during evacuation.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS, T-SERIES TRANSIT BUS, MB II SCHOOL BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E011000·2020-03-06

    Joyson Recalls Rear Seat Belt Retractors for Restraint Failure

    Joyson is recalling certain rear seat belt retractors because the locking mechanism may not properly restrain occupants, increasing injury risk in a crash.

    Product
    SEAT BELTS:REAR/OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V134000·2020-03-06

    Triple E RV Recalls 2020 Wonder Travel Trailers Due to Fire Risk

    Triple E Recreational Vehicles is recalling 2020 Wonder travel trailers because unprotected ceiling light wires can chafe and arc, increasing the risk of a fire.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20720·2020-03-05

    RH Recalls Camino Floor Lamps Due to Fire Hazard

    RH is recalling about 800 Camino floor lamps sold in the U.S. because the foot switch can overheat or catch fire, posing a fire hazard.

    Product
    Camino Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20086·2020-03-05

    ECHO and Shindaiwa Recall Backpack Blowers Due to Laceration Hazards

    ECHO and Shindaiwa are recalling about 67,700 backpack blowers and 6,600 replacement straps because parts can be expelled, posing laceration and impact risks.

    Product
    ECHO and Shindaiwa Backpack Blowers and replacement straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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